{"title":"Correction to: Characteristics of patients with extracranial cervical artery dissections involving more than a single vessels: A subgroup analysis of STOP-CAD.","authors":"","doi":"10.1093/esj/aakag017","DOIUrl":"10.1093/esj/aakag017","url":null,"abstract":"","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":"11 2","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12926221/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147272393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1093/esj/23969873251350141
Jae-Sung Lim, Joung-Ho Rha, Jong-Ho Park, Kyungbok Lee, Dae-Il Chang, Sung Hyuk Heo, Yeong Bae Lee, Jee-Hyun Kwon, Eung-Gyu Kim, Jay Chol Choi, Man-Seok Park, Kyung-Hee Cho, Jae-Kwan Cha, Mi Sun Oh, Byung-Chul Lee, Hahn Young Kim, Kyungmi Oh, Hyun-Young Park, Sanghak Yi, Tai Hwan Park, Jae-Hyeok Heo, Keun-Hwa Jung, Chulho Kim, Soo Joo Lee, Jae Guk Kim, Dong-Eog Kim, Jong-Moo Park, Kyusik Kang, Jun Hong Lee, Jong-Won Chung, Kwang-Yeol Park, Won-Jin Moon, Hyuntae Park, Seongryu Bae, Yeonwook Kang, Hannah Jung, Juneyoung Lee, Hee-Joon Bae
Introduction: This multicenter, double-blind, placebo-controlled trial, commissioned by South Korea's Ministry of Food and Drug Safety, evaluated the effect of oxiracetam for preventing post-stroke cognitive impairment (PSCI) and explored potential interaction with physical activity using neuroimaging.
Patients and methods: Patients at high risk of PSCI, reporting subjective cognitive decline ⩾3 months after stroke, were randomized 1:1 to receive oxiracetam or placebo for 36 weeks. Physical activity was tracked via wrist-worn actigraphy. Coprimary endpoints were changes in Mini-Mental State Examination (MMSE) and Clinical Dementia Rating-Sum of Boxes (CDR-SB). Secondary outcomes included neuropsychological assessments and resting-state functional magnetic resonance imaging network metrics.
Results: Of 500 enrolled participants (mean age 68.9 years; median 32 months post-stroke), 457 completed the study. There were no statistically significant differences between groups in changes in MMSE (oxiracetam: +0.13 ± 2.27 vs placebo: +0.27 ± 2.09; p = 0.49) or CDR-SB scores (-0.14 ± 0.70 vs -0.08 ± 0.80; p = 0.38). No evidence of interaction was observed between oxiracetam and physical activity. Exploratory analyses suggested favorable trends in functional segregation and CDR-SB scores among highly active oxiracetam participants.
Discussion and conclusion: Oxiracetam did not demonstrate benefit in preventing PSCI in high-risk patients. These findings support the recent regulatory decision to suspend its use in South Korea.
这项多中心、双盲、安慰剂对照试验由韩国食品和药物安全部委托进行,评估了奥拉西坦预防脑卒中后认知障碍(PSCI)的效果,并利用神经成像技术探讨了奥拉西坦与体育活动的潜在相互作用。患者和方法:卒中后报告主观认知能力下降大于或等于3个月的PSCI高风险患者按1:1随机分配,接受奥拉西坦或安慰剂治疗36周。身体活动通过腕式活动记录仪进行跟踪。主要终点是迷你精神状态检查(MMSE)和临床痴呆评分-盒和(CDR-SB)的变化。次要结果包括神经心理学评估和静息状态功能磁共振成像网络指标。结果:500名参与者(平均年龄68.9岁,中位中风后32个月)中,457人完成了研究。两组患者MMSE(奥拉西坦:+0.13±2.27 vs安慰剂:+0.27±2.09;p = 0.49)或CDR-SB评分(-0.14±0.70 vs -0.08±0.80;p = 0.38)的变化无统计学差异。没有证据表明奥拉西坦与体力活动之间存在相互作用。探索性分析表明,在高活性奥拉西坦参与者中,功能分离和CDR-SB评分有良好的趋势。讨论与结论:奥拉西坦在预防高危患者PSCI方面没有显示出益处。这些发现支持了最近监管部门暂停在韩国使用该药物的决定。
{"title":"Oxiracetam and physical activity in preventing cognitive decline after stroke: A multicenter, randomized controlled trial.","authors":"Jae-Sung Lim, Joung-Ho Rha, Jong-Ho Park, Kyungbok Lee, Dae-Il Chang, Sung Hyuk Heo, Yeong Bae Lee, Jee-Hyun Kwon, Eung-Gyu Kim, Jay Chol Choi, Man-Seok Park, Kyung-Hee Cho, Jae-Kwan Cha, Mi Sun Oh, Byung-Chul Lee, Hahn Young Kim, Kyungmi Oh, Hyun-Young Park, Sanghak Yi, Tai Hwan Park, Jae-Hyeok Heo, Keun-Hwa Jung, Chulho Kim, Soo Joo Lee, Jae Guk Kim, Dong-Eog Kim, Jong-Moo Park, Kyusik Kang, Jun Hong Lee, Jong-Won Chung, Kwang-Yeol Park, Won-Jin Moon, Hyuntae Park, Seongryu Bae, Yeonwook Kang, Hannah Jung, Juneyoung Lee, Hee-Joon Bae","doi":"10.1093/esj/23969873251350141","DOIUrl":"10.1093/esj/23969873251350141","url":null,"abstract":"<p><strong>Introduction: </strong>This multicenter, double-blind, placebo-controlled trial, commissioned by South Korea's Ministry of Food and Drug Safety, evaluated the effect of oxiracetam for preventing post-stroke cognitive impairment (PSCI) and explored potential interaction with physical activity using neuroimaging.</p><p><strong>Patients and methods: </strong>Patients at high risk of PSCI, reporting subjective cognitive decline ⩾3 months after stroke, were randomized 1:1 to receive oxiracetam or placebo for 36 weeks. Physical activity was tracked via wrist-worn actigraphy. Coprimary endpoints were changes in Mini-Mental State Examination (MMSE) and Clinical Dementia Rating-Sum of Boxes (CDR-SB). Secondary outcomes included neuropsychological assessments and resting-state functional magnetic resonance imaging network metrics.</p><p><strong>Results: </strong>Of 500 enrolled participants (mean age 68.9 years; median 32 months post-stroke), 457 completed the study. There were no statistically significant differences between groups in changes in MMSE (oxiracetam: +0.13 ± 2.27 vs placebo: +0.27 ± 2.09; p = 0.49) or CDR-SB scores (-0.14 ± 0.70 vs -0.08 ± 0.80; p = 0.38). No evidence of interaction was observed between oxiracetam and physical activity. Exploratory analyses suggested favorable trends in functional segregation and CDR-SB scores among highly active oxiracetam participants.</p><p><strong>Discussion and conclusion: </strong>Oxiracetam did not demonstrate benefit in preventing PSCI in high-risk patients. These findings support the recent regulatory decision to suspend its use in South Korea.</p>","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":"11 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12866270/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146087574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Identifying patients with minor stroke is challenging in the prehospital setting due to subtle symptoms. The majority of studies evaluating prehospital stroke scales include patients with high median NIHSS at admission. ParaNASPP, a stepped-wedge cluster-randomized controlled trial found that prehospital NIHSS identified more patients with minor symptoms. Further knowledge on presenting symptoms of patients with suspected minor stroke, and the accuracy of prehospital stroke scales on minor stroke is needed.
Methods: A post-hoc analysis of data from the ParaNASPP trial describes prehospital presenting signs and symptoms of patients with suspected mild minor stroke. We defined mild minor stroke as NIHSS 0-2 at hospital admission. Furthermore, we reconstructed and evaluated nine prehospital stroke scales (NIHSS, FAST/CPSS, BE-FAST, LAPSS, MASS, MedPacs, PreHAST, and sNIHSS-EMS) in patients with mild minor stroke.
Results: Four hundred and thirty-one patients in the ParaNASPP trial had NIHSS 0-2 at hospital admission. Of these, 152 (35%) were discharged from hospital with a stroke diagnosis. When examined by paramedics, stroke patients presented with speech disturbance, facial palsy, and motor weakness in arm or leg, while stroke mimics presented with dizziness, headache, and nausea/vomiting. NIHSS had the highest sensitivity (95%) and lowest specificity (16%), while LAPSS had the lowest sensitivity (42%) and highest specificity (80%) in the patients with suspected mild minor stroke. The remaining scales had sensitivity between 67% and 93%, and specificity between 23% and 67%.
Conclusions: In patients with mild minor stroke, substantial overlap in presentation between stroke and stroke mimics makes triage challenging. Prehospital stroke scales provide either high sensitivity or specificity. Competence and training of paramedics in when and how to use, and interpret, these scales is key for recognizing and correctly triaging stroke patients.The ParaNASPP trial was registered at Clinicaltrials.gov with registration number NCT04137874.
{"title":"Presenting symptoms and diagnostic accuracy of prehospital stroke scales for patients with suspected mild minor stroke.","authors":"Helge Fagerheim Bugge, Mona Guterud, Karianne Larsen, Mathias Toft, Maren Ranhoff Hov, Else Charlotte Sandset","doi":"10.1093/esj/23969873251360592","DOIUrl":"10.1093/esj/23969873251360592","url":null,"abstract":"<p><strong>Introduction: </strong>Identifying patients with minor stroke is challenging in the prehospital setting due to subtle symptoms. The majority of studies evaluating prehospital stroke scales include patients with high median NIHSS at admission. ParaNASPP, a stepped-wedge cluster-randomized controlled trial found that prehospital NIHSS identified more patients with minor symptoms. Further knowledge on presenting symptoms of patients with suspected minor stroke, and the accuracy of prehospital stroke scales on minor stroke is needed.</p><p><strong>Methods: </strong>A post-hoc analysis of data from the ParaNASPP trial describes prehospital presenting signs and symptoms of patients with suspected mild minor stroke. We defined mild minor stroke as NIHSS 0-2 at hospital admission. Furthermore, we reconstructed and evaluated nine prehospital stroke scales (NIHSS, FAST/CPSS, BE-FAST, LAPSS, MASS, MedPacs, PreHAST, and sNIHSS-EMS) in patients with mild minor stroke.</p><p><strong>Results: </strong>Four hundred and thirty-one patients in the ParaNASPP trial had NIHSS 0-2 at hospital admission. Of these, 152 (35%) were discharged from hospital with a stroke diagnosis. When examined by paramedics, stroke patients presented with speech disturbance, facial palsy, and motor weakness in arm or leg, while stroke mimics presented with dizziness, headache, and nausea/vomiting. NIHSS had the highest sensitivity (95%) and lowest specificity (16%), while LAPSS had the lowest sensitivity (42%) and highest specificity (80%) in the patients with suspected mild minor stroke. The remaining scales had sensitivity between 67% and 93%, and specificity between 23% and 67%.</p><p><strong>Conclusions: </strong>In patients with mild minor stroke, substantial overlap in presentation between stroke and stroke mimics makes triage challenging. Prehospital stroke scales provide either high sensitivity or specificity. Competence and training of paramedics in when and how to use, and interpret, these scales is key for recognizing and correctly triaging stroke patients.The ParaNASPP trial was registered at Clinicaltrials.gov with registration number NCT04137874.</p>","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":"11 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12866222/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146087614","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1093/esj/23969873251343857
Marko Vilpponen, Aapo L Aro, Olli Halminen, Paula Tiili, Miika Linna, Alex Luojus, Konsta Teppo, Pirjo Mustonen, Jari Haukka, Juha Hartikainen, K E Juhani Airaksinen, Mika Lehto, Jukka Putaala
Background: Limited data exist on characteristics and patterns associated with patients with atrial fibrillation (AF) who encounter first-ever ischemic stroke (IS) while not on oral anticoagulation (OAC) therapy.
Methods: From a nationwide registry-linkage database including all patients with AF in Finland from 2007 to 2017, we included those with IS after diagnosis of AF and those without IS. Factors associated with non-OAC use among IS patients were examined using logistic regression, with separate models for independent variables and risk scores.
Results: Among 174,094 patients with new-onset AF, 11,680 (6.7%) patients (56.9% female; mean age 79.0 years) experienced IS. A total of 7507 (64.3%) of IS patients were not on OAC at the time of IS (mean age 78.9 years; 57.2% female). The proportion of non-OAC decreased from 77.2% to 45.6% over the study period. In the adjusted logistic regression model, the strongest factor associated with non-OAC was CHA2DS2-VA score of 0 points (OR 4.561; 95% CI, 3.097-6.718), followed by a score of 1 point (OR 2.382; 95% CI, 1.971-2.879). Other significant independent factors associated with non-OAC use were alcohol abuse (OR 2.282; 95% CI, 1.805-2.885), liver dysfunction (OR 2.120; 95% CI, 1.335-3.367), renal dysfunction (OR 1.430; 95% CI, 1.200-1.703), dementia (OR 1.394; 95% CI, 1.227-1.583), prior myocardial infarction (OR 1.346; 95% CI, 1.181-1.535), age <65 years (OR 1.274; 95% CI, 1.034-1.571), lowest income (OR 1.232; 95% CI, 1.104-1.374), female sex (OR 1.177; 95% CI, 1.077-1.287), and antiplatelets/NSAID use (OR 1.133; 95% CI, 1.042-1.231).
Conclusions: Less than 2% of AF patients experienced IS during study period and among these around 63% were without appropriate OAC therapy at the time of the IS. However, decreasing trend of non-OAC use was identified throughout the study period.
{"title":"Factors associated with oral anticoagulant non-use at first ischemic stroke in atrial fibrillation: A nationwide study.","authors":"Marko Vilpponen, Aapo L Aro, Olli Halminen, Paula Tiili, Miika Linna, Alex Luojus, Konsta Teppo, Pirjo Mustonen, Jari Haukka, Juha Hartikainen, K E Juhani Airaksinen, Mika Lehto, Jukka Putaala","doi":"10.1093/esj/23969873251343857","DOIUrl":"10.1093/esj/23969873251343857","url":null,"abstract":"<p><strong>Background: </strong>Limited data exist on characteristics and patterns associated with patients with atrial fibrillation (AF) who encounter first-ever ischemic stroke (IS) while not on oral anticoagulation (OAC) therapy.</p><p><strong>Methods: </strong>From a nationwide registry-linkage database including all patients with AF in Finland from 2007 to 2017, we included those with IS after diagnosis of AF and those without IS. Factors associated with non-OAC use among IS patients were examined using logistic regression, with separate models for independent variables and risk scores.</p><p><strong>Results: </strong>Among 174,094 patients with new-onset AF, 11,680 (6.7%) patients (56.9% female; mean age 79.0 years) experienced IS. A total of 7507 (64.3%) of IS patients were not on OAC at the time of IS (mean age 78.9 years; 57.2% female). The proportion of non-OAC decreased from 77.2% to 45.6% over the study period. In the adjusted logistic regression model, the strongest factor associated with non-OAC was CHA2DS2-VA score of 0 points (OR 4.561; 95% CI, 3.097-6.718), followed by a score of 1 point (OR 2.382; 95% CI, 1.971-2.879). Other significant independent factors associated with non-OAC use were alcohol abuse (OR 2.282; 95% CI, 1.805-2.885), liver dysfunction (OR 2.120; 95% CI, 1.335-3.367), renal dysfunction (OR 1.430; 95% CI, 1.200-1.703), dementia (OR 1.394; 95% CI, 1.227-1.583), prior myocardial infarction (OR 1.346; 95% CI, 1.181-1.535), age <65 years (OR 1.274; 95% CI, 1.034-1.571), lowest income (OR 1.232; 95% CI, 1.104-1.374), female sex (OR 1.177; 95% CI, 1.077-1.287), and antiplatelets/NSAID use (OR 1.133; 95% CI, 1.042-1.231).</p><p><strong>Conclusions: </strong>Less than 2% of AF patients experienced IS during study period and among these around 63% were without appropriate OAC therapy at the time of the IS. However, decreasing trend of non-OAC use was identified throughout the study period.</p>","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":"11 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12866281/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146087506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1093/esj/23969873251368720
Fabrizio Sallustio, Alfredo Paolo Mascolo, Federico Marrama, Marina Diomedi, Giordano Lacidogna, Federica D'Agostino, Fana Alemseged, Valerio Da Ros, Federico Sabuzi, Enrico Fainardi, Ilaria Casetta, Stefano Vallone, Guido Bigliardi, Luca Allegretti, Elena Coco, Elvis Lafe, Marco Longoni, Vittorio Semeraro, Giovanni Boero, Benedetto Petralia, Manuel Cappellari, Ettore Nicolini, Antonio Ciacciarelli, Rosa Napoletano, Andrea Boghi, Andrea Naldi, Andrea Saletti, Alessandro De Vito, Sergio Lucio Vinci, Ludovica Ferraù, Domenico Sergio Zimatore, Marco Petruzzellis, Mauro Bergui, Giovanni Bosco, Ivan Gallesio, Delfina Ferrandi, Mirco Cosottini, Nicola Giannini, Alessio Comai, Elisa Dall'Ora, Giovanni Barchetti, Marcella Caggiula, Nicola Cavasin, Adriana Critelli, Marco Perri, Federica De Santis, Simone Galluzzo, Andrea Zini, Simone Zilahi De Gyurgyokai, Nicola Loizzo, Roberto Menozzi, Alessandro Pezzini, Massimo Sponza, Giovanni Merlino, Marco Filizzolo, Marina Mannino, Giuseppe Carità, Monia Russo, Massimiliano Allegritti, Stefano Caproni, Michele Besana, Alessia Giossi, Samuele Cioni, Rossana Tassi, Gianluca Galvano, Eleonora Saracco, Nicola Limbucci, Edoardo Puglielli, Alfonsina Casalena, Salvatore Mangiafico, Danilo Toni
Introduction: We aim to evaluate the association between door-to-needle time (DTN) and outcomes in a population of acute ischemic stroke (AIS) patients treated with intravenous thrombolysis (IVT) + mechanical thrombectomy (MT) in the Italian Registry of Endovascular Treatment in Acute Stroke (IRETAS).
Materials and methods: Patients with AIS secondary to middle cerebral artery or intracranial internal carotid artery occlusion with known times of symptoms onset, directly presenting to an MT-capable center, were included in the analysis. According to pre-defined DTN cut-off values (⩽30, ⩽45, and ⩽60 min), we evaluated the association between DTN and outcomes by multivariate logistic regression analyses. Effectiveness outcomes were 3-month functional independence, 3-month excellent outcome and successful reperfusion. Safety outcomes were any intracranial hemorrhage (ICH), symptomatic intracerebral hemorrhage (sICH), and 3-month mortality.
Results: About 1602 patients were included in our analysis. After logistic regression analysis, a DTN ⩽ 60 min was significantly associated with 3-month functional independence (OR 1.36; 95% CI 1.02-1.82). DTNs ⩽ 30, ⩽45, and ⩽60 min were significantly associated with successful reperfusion (OR 2.66; 95% CI 1.6-4.43; OR 1.68; 95%CI 1.25-2.26; OR 1.57; 95% CI 1.21-2.05; respectively). A DTN ⩽ 60 min was also significantly associated with lower rate of any ICH (OR 0.61; 95% CI 0.43-0.86). DTNs ⩽ 30, ⩽45, and ⩽60 min were significantly associated with lower 3-month mortality (OR 0.24; 95% CI 0.08-0.67; OR 0.45; 95% CI 0.29-0.72; OR 0.58; 95% CI 0.39-0.84; respectively).
Conclusions: In patients with AIS treated with IVT + MT, a shorter DTN is associated with better outcomes if IVT is initiated within 1 h of hospital admission.
在意大利急性卒中血管内治疗登记处(IRETAS)中,我们旨在评估接受静脉溶栓(IVT) +机械取栓(MT)治疗的急性缺血性卒中(AIS)患者的门到针时间(DTN)与预后之间的关系。材料和方法:已知症状发作时间的继发于大脑中动脉或颅内颈内动脉闭塞的AIS患者,直接到具有mt能力的中心就诊,纳入分析。根据预先定义的DTN截断值(≥30分钟,≥45分钟和≥60分钟),我们通过多变量逻辑回归分析评估DTN与预后之间的关系。疗效结果为3个月功能独立,3个月预后良好,再灌注成功。安全性指标为颅内出血(ICH)、症状性脑出血(sICH)和3个月死亡率。结果:约1602例患者纳入我们的分析。经logistic回归分析,DTN≥60 min与3个月功能独立性显著相关(OR 1.36; 95% CI 1.02-1.82)。dns≥30、≥45、≥60 min与再灌注成功相关(OR分别为2.66;95%CI 1.6-4.43; OR 1.68; 95%CI 1.25-2.26; OR 1.57; 95%CI 1.21-2.05)。DTN≤60 min也与较低的ICH发生率显著相关(OR 0.61; 95% CI 0.43-0.86)。dns≥30、≥45和≥60 min与较低的3个月死亡率显著相关(分别为OR 0.24; 95% CI 0.08-0.67; OR 0.45; 95% CI 0.29-0.72; OR 0.58; 95% CI 0.39-0.84)。结论:在接受IVT + MT治疗的AIS患者中,如果在入院后1小时内开始IVT,较短的DTN与较好的预后相关。
{"title":"Association between door-to-needle time and outcomes in acute ischemic stroke patients treated with intravenous thrombolysis plus mechanical thrombectomy: Analysis from the Italian Registry of Endovascular Treatment in Acute Stroke (IRETAS).","authors":"Fabrizio Sallustio, Alfredo Paolo Mascolo, Federico Marrama, Marina Diomedi, Giordano Lacidogna, Federica D'Agostino, Fana Alemseged, Valerio Da Ros, Federico Sabuzi, Enrico Fainardi, Ilaria Casetta, Stefano Vallone, Guido Bigliardi, Luca Allegretti, Elena Coco, Elvis Lafe, Marco Longoni, Vittorio Semeraro, Giovanni Boero, Benedetto Petralia, Manuel Cappellari, Ettore Nicolini, Antonio Ciacciarelli, Rosa Napoletano, Andrea Boghi, Andrea Naldi, Andrea Saletti, Alessandro De Vito, Sergio Lucio Vinci, Ludovica Ferraù, Domenico Sergio Zimatore, Marco Petruzzellis, Mauro Bergui, Giovanni Bosco, Ivan Gallesio, Delfina Ferrandi, Mirco Cosottini, Nicola Giannini, Alessio Comai, Elisa Dall'Ora, Giovanni Barchetti, Marcella Caggiula, Nicola Cavasin, Adriana Critelli, Marco Perri, Federica De Santis, Simone Galluzzo, Andrea Zini, Simone Zilahi De Gyurgyokai, Nicola Loizzo, Roberto Menozzi, Alessandro Pezzini, Massimo Sponza, Giovanni Merlino, Marco Filizzolo, Marina Mannino, Giuseppe Carità, Monia Russo, Massimiliano Allegritti, Stefano Caproni, Michele Besana, Alessia Giossi, Samuele Cioni, Rossana Tassi, Gianluca Galvano, Eleonora Saracco, Nicola Limbucci, Edoardo Puglielli, Alfonsina Casalena, Salvatore Mangiafico, Danilo Toni","doi":"10.1093/esj/23969873251368720","DOIUrl":"10.1093/esj/23969873251368720","url":null,"abstract":"<p><strong>Introduction: </strong>We aim to evaluate the association between door-to-needle time (DTN) and outcomes in a population of acute ischemic stroke (AIS) patients treated with intravenous thrombolysis (IVT) + mechanical thrombectomy (MT) in the Italian Registry of Endovascular Treatment in Acute Stroke (IRETAS).</p><p><strong>Materials and methods: </strong>Patients with AIS secondary to middle cerebral artery or intracranial internal carotid artery occlusion with known times of symptoms onset, directly presenting to an MT-capable center, were included in the analysis. According to pre-defined DTN cut-off values (⩽30, ⩽45, and ⩽60 min), we evaluated the association between DTN and outcomes by multivariate logistic regression analyses. Effectiveness outcomes were 3-month functional independence, 3-month excellent outcome and successful reperfusion. Safety outcomes were any intracranial hemorrhage (ICH), symptomatic intracerebral hemorrhage (sICH), and 3-month mortality.</p><p><strong>Results: </strong>About 1602 patients were included in our analysis. After logistic regression analysis, a DTN ⩽ 60 min was significantly associated with 3-month functional independence (OR 1.36; 95% CI 1.02-1.82). DTNs ⩽ 30, ⩽45, and ⩽60 min were significantly associated with successful reperfusion (OR 2.66; 95% CI 1.6-4.43; OR 1.68; 95%CI 1.25-2.26; OR 1.57; 95% CI 1.21-2.05; respectively). A DTN ⩽ 60 min was also significantly associated with lower rate of any ICH (OR 0.61; 95% CI 0.43-0.86). DTNs ⩽ 30, ⩽45, and ⩽60 min were significantly associated with lower 3-month mortality (OR 0.24; 95% CI 0.08-0.67; OR 0.45; 95% CI 0.29-0.72; OR 0.58; 95% CI 0.39-0.84; respectively).</p><p><strong>Conclusions: </strong>In patients with AIS treated with IVT + MT, a shorter DTN is associated with better outcomes if IVT is initiated within 1 h of hospital admission.</p>","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":"11 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12866252/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146086836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1093/esj/23969873251329210
Erlend Fagerli, Hanne Ellekjær, Olav Spigset, Ingvild Saltvedt, Mari Nordbø Gynnild
Introduction: Long-term adherence to secondary prevention after ischemic stroke remains unclear. This study aimed to evaluate medication adherence, attainment of vascular treatment targets, and clinical characteristics that influence target achievement 3 years post-stroke.
Patients and methods: We included 665 home-dwelling ischemic stroke patients from the Norwegian Cognitive Impairment After Stroke study, admitted between May 2015 and March 2017 (n = 431 were followed for 3 years). Medication adherence was assessed using the 4-item Morisky Medication Adherence Scale, medication persistence, and guideline-based treatment targets: blood pressure (BP) < 140/90 mmHg, LDL cholesterol (LDL-C) < 2.0 mmol/L, and hemoglobin A1c (HbA1c) ⩽ 53 mmol/mol.
Results: At discharge, prescription rates were 97% for antithrombotics, 67% for antihypertensives, 88% for lipid-lowering drugs (LLD), and 10% for antidiabetics. Three years later, persistence rates were 97%, 91%, 83%, and 94%, respectively, with 73% reporting high medication adherence. Target achievement rates were 42% for BP, 47% for LDL-C, and 75% for HbA1c among diabetic patients. Younger age was associated with better BP control (OR 0.974 per year, 95% CI 0.957-0.992). Women had poorer LDL-C control (OR 0.55, 95% CI 0.33-0.91). More LLD (OR 1.25, 95% CI 1.14-1.37) and higher comorbidity (OR 1.26, 95% CI 1.10-1.44) were associated with improved LDL-C control.
Conclusion: Control of risk factors remained unsatisfactory 3 years after ischemic stroke, despite relatively high persistence and adherence rates. Improved focus on implementing optimal secondary prevention for Norwegian stroke patients is necessary.
简介:缺血性卒中后二级预防的长期依从性尚不清楚。本研究旨在评估卒中后3年患者的药物依从性、血管治疗目标的实现以及影响目标实现的临床特征。患者和方法:我们纳入了2015年5月至2017年3月期间入院的挪威卒中后认知障碍研究中的665例居家缺血性卒中患者(n = 431例,随访3年)。用药依从性采用Morisky药物依从性量表、用药持久性和基于指南的治疗目标:血压(BP)进行评估。结果:出院时,抗血栓药物的处方率为97%,抗高血压药物为67%,降脂药物(LLD)为88%,降糖药为10%。三年后,坚持率分别为97%、91%、83%和94%,其中73%报告高药物依从性。糖尿病患者血压、LDL-C和HbA1c的目标完成率分别为42%、47%和75%。年龄越小,血压控制越好(OR 0.974 /年,95% CI 0.957-0.992)。女性LDL-C控制较差(OR 0.55, 95% CI 0.33-0.91)。更多的低密度脂蛋白(OR 1.25, 95% CI 1.14-1.37)和更高的合并症(OR 1.26, 95% CI 1.10-1.44)与LDL-C控制的改善相关。结论:缺血性卒中后3年的危险因素控制仍不理想,尽管相对较高的坚持和依从率。加强对挪威卒中患者实施最佳二级预防的关注是必要的。
{"title":"Three-year adherence to secondary prevention and vascular risk control after ischemic stroke.","authors":"Erlend Fagerli, Hanne Ellekjær, Olav Spigset, Ingvild Saltvedt, Mari Nordbø Gynnild","doi":"10.1093/esj/23969873251329210","DOIUrl":"10.1093/esj/23969873251329210","url":null,"abstract":"<p><strong>Introduction: </strong>Long-term adherence to secondary prevention after ischemic stroke remains unclear. This study aimed to evaluate medication adherence, attainment of vascular treatment targets, and clinical characteristics that influence target achievement 3 years post-stroke.</p><p><strong>Patients and methods: </strong>We included 665 home-dwelling ischemic stroke patients from the Norwegian Cognitive Impairment After Stroke study, admitted between May 2015 and March 2017 (n = 431 were followed for 3 years). Medication adherence was assessed using the 4-item Morisky Medication Adherence Scale, medication persistence, and guideline-based treatment targets: blood pressure (BP) < 140/90 mmHg, LDL cholesterol (LDL-C) < 2.0 mmol/L, and hemoglobin A1c (HbA1c) ⩽ 53 mmol/mol.</p><p><strong>Results: </strong>At discharge, prescription rates were 97% for antithrombotics, 67% for antihypertensives, 88% for lipid-lowering drugs (LLD), and 10% for antidiabetics. Three years later, persistence rates were 97%, 91%, 83%, and 94%, respectively, with 73% reporting high medication adherence. Target achievement rates were 42% for BP, 47% for LDL-C, and 75% for HbA1c among diabetic patients. Younger age was associated with better BP control (OR 0.974 per year, 95% CI 0.957-0.992). Women had poorer LDL-C control (OR 0.55, 95% CI 0.33-0.91). More LLD (OR 1.25, 95% CI 1.14-1.37) and higher comorbidity (OR 1.26, 95% CI 1.10-1.44) were associated with improved LDL-C control.</p><p><strong>Conclusion: </strong>Control of risk factors remained unsatisfactory 3 years after ischemic stroke, despite relatively high persistence and adherence rates. Improved focus on implementing optimal secondary prevention for Norwegian stroke patients is necessary.</p>","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":"11 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12863440/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146086924","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1093/esj/23969873251343814
Adnan I Qureshi
{"title":"Intra-arterial thrombolysis as an adjunct to thrombectomy in acute ischemic stroke: Encouraging but not conclusive evidence.","authors":"Adnan I Qureshi","doi":"10.1093/esj/23969873251343814","DOIUrl":"10.1093/esj/23969873251343814","url":null,"abstract":"","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":"11 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12866212/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146087147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Francesco Fisicaro, Mariagiovanna Cantone, Klizia Cortese, Raffaele Ferri, Giuseppe Lanza, Christian Messina, Manuela Pennisi, Marialuisa Zedde, Mario Zappia, Rita Bella
Introduction: Right-to-left shunt (RLS) associated with a patent foramen ovale has been related with ischemic stroke. However, its relationship with MRI white matter hyperintensities (WMHs) remains debated. This cross-sectional, single-centre study investigated the prevalence of RLS detected by transcranial Doppler sonography (TCD) and its association with vascular lesions on MRI.
Patients and methods: 502 outpatients (mean age 47.8 ± 13 years; 45% male) with non-specific neurological symptoms underwent brain MRI and TCD with contrast saline. WMH severity was visually graded using the Fazekas scale.
Results: RLS was detected in 39% of the sample. No difference was found in demographics and clinical variables between those with and without RLS. No association was also found between RLS and MRI lesion load. As expected, a significant (P < .001) positive correlation was identified between age and Fazekas scores (ie, higher scores with increasing age). No effect on lesion load was found for sex, hypercholesterolemia, diabetes, obesity and smoking, while a statistically significant association (P = .016) was present for arterial hypertension (odds ratio 1.68, 95% CI, 1.10-2.56; among those with higher Fazekas scores). Finally, no significant association was found between RLS magnitude, both at rest and during the Valsalva manoeuver and the Fazekas scores.
Discussion: Although RLS was frequently detected in this cohort, it was not associated with the presence or severity of WMHs, which were instead driven by age and arterial hypertension. These findings support WMHs as MRI marker of cerebral small vessel disease rather than subclinical paradoxical embolism. This also suggests limited utility of routine TCD screening for RLS in patients with incidental WMHs and no history or sign of embolic features.
Conclusions: In patients with non-specific neurological symptoms, we detected a high occurrence of RLS, although this was not associated with an increased risk or severity of WMHs. As such, paradoxical embolism may not be a major determinant of subclinical WMHs in this population.
{"title":"Transcranial doppler detected right-to-left shunt is common but not associated with MRI white matter hyperintensity burden: a cross-sectional study.","authors":"Francesco Fisicaro, Mariagiovanna Cantone, Klizia Cortese, Raffaele Ferri, Giuseppe Lanza, Christian Messina, Manuela Pennisi, Marialuisa Zedde, Mario Zappia, Rita Bella","doi":"10.1093/esj/aakaf029","DOIUrl":"10.1093/esj/aakaf029","url":null,"abstract":"<p><strong>Introduction: </strong>Right-to-left shunt (RLS) associated with a patent foramen ovale has been related with ischemic stroke. However, its relationship with MRI white matter hyperintensities (WMHs) remains debated. This cross-sectional, single-centre study investigated the prevalence of RLS detected by transcranial Doppler sonography (TCD) and its association with vascular lesions on MRI.</p><p><strong>Patients and methods: </strong>502 outpatients (mean age 47.8 ± 13 years; 45% male) with non-specific neurological symptoms underwent brain MRI and TCD with contrast saline. WMH severity was visually graded using the Fazekas scale.</p><p><strong>Results: </strong>RLS was detected in 39% of the sample. No difference was found in demographics and clinical variables between those with and without RLS. No association was also found between RLS and MRI lesion load. As expected, a significant (P < .001) positive correlation was identified between age and Fazekas scores (ie, higher scores with increasing age). No effect on lesion load was found for sex, hypercholesterolemia, diabetes, obesity and smoking, while a statistically significant association (P = .016) was present for arterial hypertension (odds ratio 1.68, 95% CI, 1.10-2.56; among those with higher Fazekas scores). Finally, no significant association was found between RLS magnitude, both at rest and during the Valsalva manoeuver and the Fazekas scores.</p><p><strong>Discussion: </strong>Although RLS was frequently detected in this cohort, it was not associated with the presence or severity of WMHs, which were instead driven by age and arterial hypertension. These findings support WMHs as MRI marker of cerebral small vessel disease rather than subclinical paradoxical embolism. This also suggests limited utility of routine TCD screening for RLS in patients with incidental WMHs and no history or sign of embolic features.</p><p><strong>Conclusions: </strong>In patients with non-specific neurological symptoms, we detected a high occurrence of RLS, although this was not associated with an increased risk or severity of WMHs. As such, paradoxical embolism may not be a major determinant of subclinical WMHs in this population.</p>","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":"11 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12866658/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146087173","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-01-01DOI: 10.1093/esj/23969873251369755
Lukas Nussbaum, Sabine Schaedelin, Leo Bonati, Marcel Arnold, David J Seiffge, Martina Goeldlin, Stefan Engelter, Alexandros A Polymeris, Timo Kahles, Krassen Nedeltchev, Georg Kägi, Davide Strambo, Alexander Salerno, Emmanuel Carrera, Susanne Wegener, Carlo Cereda, Manuel Bolognese, Lehel-Barna Lakatos, Andrea Humm, Friedrich Medlin, Nils Peters, Dennis Thumm, Sylvan Albert, Maria Ligon, Christian Berger, Marie-Luise Mono, Susanne Renaud, Julien Niederhauser, Alexander Tarnutzer, Nicole Bruni, Mira Katan, Gian Marco De Marchis, Philippe Lyrer
Introduction: Whether patients with acute ischaemic stroke (AIS) and prior antiplatelet therapy (APT) are at higher risk of symptomatic intracranial haemorrhage (sICH) has not been established. This study aimed to determine whether prior APT increases the risk of bleeding.
Methods: 41,113 patients treated for AIS in Switzerland between 2014 and 2022 were analysed. The primary outcome was sICH, and secondary outcomes were recurrent ischaemic stroke (IS), all-cause mortality, functional outcome at discharge and 90 days. Patients grouped by prior APT: no APT (nAPT), single APT (SAPT), and dual APT (DAPT) were analysed using logistic and Cox proportional hazards regression. Confounding variables, including revascularisation treatment, were accounted for using multivariable adjustment and matching, and a time-to-event analysis was performed.
Results: In the adjusted analysis at 90 days, patients with nAPT versus SAPT had a decreased risk of sICH (aOR 0.75 (0.62-0.90), p < 0.01), while these occurred within the first days. There was no difference in the risk of recurrent IS, all-cause mortality, or functional outcome. Patients with DAPT had no higher risk of sICH or mortality than those with SAPT, but a higher occurrence of recurrent IS (aOR 1.41 (1.12-1.77), p < 0.01) and worse functional outcome (aOR 1.18 (1.07-1.31), p < 0.01). The results were consistent after adjusting for revascularisation treatment.
Conclusions: Patients with nAPT had a lower risk of sICH than those with SAPT. Patients with DAPT have a higher risk of recurrent IS and worse functional outcome respectively. The majority of sICH occurred within the first days after admission.
{"title":"Risk of intracranial haemorrhage in patients with acute ischaemic stroke and prior antiplatelet therapy.","authors":"Lukas Nussbaum, Sabine Schaedelin, Leo Bonati, Marcel Arnold, David J Seiffge, Martina Goeldlin, Stefan Engelter, Alexandros A Polymeris, Timo Kahles, Krassen Nedeltchev, Georg Kägi, Davide Strambo, Alexander Salerno, Emmanuel Carrera, Susanne Wegener, Carlo Cereda, Manuel Bolognese, Lehel-Barna Lakatos, Andrea Humm, Friedrich Medlin, Nils Peters, Dennis Thumm, Sylvan Albert, Maria Ligon, Christian Berger, Marie-Luise Mono, Susanne Renaud, Julien Niederhauser, Alexander Tarnutzer, Nicole Bruni, Mira Katan, Gian Marco De Marchis, Philippe Lyrer","doi":"10.1093/esj/23969873251369755","DOIUrl":"10.1093/esj/23969873251369755","url":null,"abstract":"<p><strong>Introduction: </strong>Whether patients with acute ischaemic stroke (AIS) and prior antiplatelet therapy (APT) are at higher risk of symptomatic intracranial haemorrhage (sICH) has not been established. This study aimed to determine whether prior APT increases the risk of bleeding.</p><p><strong>Methods: </strong>41,113 patients treated for AIS in Switzerland between 2014 and 2022 were analysed. The primary outcome was sICH, and secondary outcomes were recurrent ischaemic stroke (IS), all-cause mortality, functional outcome at discharge and 90 days. Patients grouped by prior APT: no APT (nAPT), single APT (SAPT), and dual APT (DAPT) were analysed using logistic and Cox proportional hazards regression. Confounding variables, including revascularisation treatment, were accounted for using multivariable adjustment and matching, and a time-to-event analysis was performed.</p><p><strong>Results: </strong>In the adjusted analysis at 90 days, patients with nAPT versus SAPT had a decreased risk of sICH (aOR 0.75 (0.62-0.90), p < 0.01), while these occurred within the first days. There was no difference in the risk of recurrent IS, all-cause mortality, or functional outcome. Patients with DAPT had no higher risk of sICH or mortality than those with SAPT, but a higher occurrence of recurrent IS (aOR 1.41 (1.12-1.77), p < 0.01) and worse functional outcome (aOR 1.18 (1.07-1.31), p < 0.01). The results were consistent after adjusting for revascularisation treatment.</p><p><strong>Conclusions: </strong>Patients with nAPT had a lower risk of sICH than those with SAPT. Patients with DAPT have a higher risk of recurrent IS and worse functional outcome respectively. The majority of sICH occurred within the first days after admission.</p>","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":"11 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12866221/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146087639","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mukul Sharma, Qiang Dong, Teruyuki Hirano, Scott E Kasner, Jeffrey Saver, Jaime Masjuan, Andrew M Demchuk, Charlotte Cordonnier, Daniel Bereczki, Georgios Tsivgoulis, Roland Veltkamp, Ivan Staikov, Hee-Joon Bae, Bruce C V Campbell, Andrea Zini, I-Hui Lee, Sebastian Ameriso, Martin Kovar, Robert Mikulik, Robin Lemmens, José M Ferro, Thompson Robinson, Hanne Christensen, Serefnur Ozturk, Ronen R Leker, Peter Turcani, Agnieszka Slowik, Pablo Amaya, Fan Kee Hoo, Gian Marco De Marchis, Michael Knoflach, Pillai N Sylaja, Jukka Putaala, Jonathan M Coutinho, H Bart van der Worp, Evija Miglane, Vaidas Matijosaitis, Arne G Lindgren, Gisele Sampaio Silva, Else Charlotte Sandset, Saule Tleubergenovna Turuspekova, Raed A Joundi, Karleen Schulze, Olga Shestakovska, Jennifer Gilbride, Shrikant I Bangdiwala, Lizhen Xu, Eva Muehlhofer, Pablo Colorado, Hardi Mundl, Lars Keller, Ashkan Shoamanesh
Introduction: Genetic deficiency of factor XI is associated with a reduced risk of ischemic stroke. Asundexian is a direct inhibitor of activated factor XIa (FXIa) with a low risk of bleeding in early trials. We seek to determine its efficacy and safety combined with antiplatelet therapy for prevention of ischemic stroke.
Patients and methods: Oral faCtor Eleven A iNhibitor asundexian as novel antithrombotiC (OCEANIC-STROKE) is a placebo-controlled, double-blind, event-driven randomised trial including participants with stroke (NIHSS ≤ 15) or high-risk TIA (ABCD2 6 or 7) within 72 h of onset. Participants had at least one of the following: atherosclerosis of extra- or intracranial vessels, a medical history of atherosclerosis or an imaged acute non-lacunar infarct. We excluded sources of stroke requiring anticoagulation and active non-trivial bleeding other than hemorrhagic infarction (HI 1 or 2). Participants received asundexian 50 mg daily or placebo stratified by planned concurrent antiplatelet therapy (single vs dual). The primary endpoint is time to ischemic stroke. We present baseline characteristics as of 5 June 2025.
Results: Between January 2023 and February 2025, we randomised 12,327 participants. Participants were 67% male with a mean (SD) age of 68 (11) years. Ischemic stroke was the index event for 95% of whom 27.4% had thrombolysis and/or mechanical thrombectomy. By TOAST classification, 43% of index strokes were LAA, 22% small vessel disease, 30% undetermined and 2% cardioembolic. Dual antiplatelets were planned in 63% as standard initial treatment. Trial completion is anticipated in October 2025.
Conclusion: OCEANIC-STROKE will be the first completed trial of FXIa inhibition for prevention of stroke after non-cardioembolic stroke or TIA.
{"title":"Rationale, design and baseline characteristics of participants in the OCEANIC-STROKE trial of FXIa inhibition for secondary stroke prevention.","authors":"Mukul Sharma, Qiang Dong, Teruyuki Hirano, Scott E Kasner, Jeffrey Saver, Jaime Masjuan, Andrew M Demchuk, Charlotte Cordonnier, Daniel Bereczki, Georgios Tsivgoulis, Roland Veltkamp, Ivan Staikov, Hee-Joon Bae, Bruce C V Campbell, Andrea Zini, I-Hui Lee, Sebastian Ameriso, Martin Kovar, Robert Mikulik, Robin Lemmens, José M Ferro, Thompson Robinson, Hanne Christensen, Serefnur Ozturk, Ronen R Leker, Peter Turcani, Agnieszka Slowik, Pablo Amaya, Fan Kee Hoo, Gian Marco De Marchis, Michael Knoflach, Pillai N Sylaja, Jukka Putaala, Jonathan M Coutinho, H Bart van der Worp, Evija Miglane, Vaidas Matijosaitis, Arne G Lindgren, Gisele Sampaio Silva, Else Charlotte Sandset, Saule Tleubergenovna Turuspekova, Raed A Joundi, Karleen Schulze, Olga Shestakovska, Jennifer Gilbride, Shrikant I Bangdiwala, Lizhen Xu, Eva Muehlhofer, Pablo Colorado, Hardi Mundl, Lars Keller, Ashkan Shoamanesh","doi":"10.1093/esj/aakaf017","DOIUrl":"10.1093/esj/aakaf017","url":null,"abstract":"<p><strong>Introduction: </strong>Genetic deficiency of factor XI is associated with a reduced risk of ischemic stroke. Asundexian is a direct inhibitor of activated factor XIa (FXIa) with a low risk of bleeding in early trials. We seek to determine its efficacy and safety combined with antiplatelet therapy for prevention of ischemic stroke.</p><p><strong>Patients and methods: </strong>Oral faCtor Eleven A iNhibitor asundexian as novel antithrombotiC (OCEANIC-STROKE) is a placebo-controlled, double-blind, event-driven randomised trial including participants with stroke (NIHSS ≤ 15) or high-risk TIA (ABCD2 6 or 7) within 72 h of onset. Participants had at least one of the following: atherosclerosis of extra- or intracranial vessels, a medical history of atherosclerosis or an imaged acute non-lacunar infarct. We excluded sources of stroke requiring anticoagulation and active non-trivial bleeding other than hemorrhagic infarction (HI 1 or 2). Participants received asundexian 50 mg daily or placebo stratified by planned concurrent antiplatelet therapy (single vs dual). The primary endpoint is time to ischemic stroke. We present baseline characteristics as of 5 June 2025.</p><p><strong>Results: </strong>Between January 2023 and February 2025, we randomised 12,327 participants. Participants were 67% male with a mean (SD) age of 68 (11) years. Ischemic stroke was the index event for 95% of whom 27.4% had thrombolysis and/or mechanical thrombectomy. By TOAST classification, 43% of index strokes were LAA, 22% small vessel disease, 30% undetermined and 2% cardioembolic. Dual antiplatelets were planned in 63% as standard initial treatment. Trial completion is anticipated in October 2025.</p><p><strong>Conclusion: </strong>OCEANIC-STROKE will be the first completed trial of FXIa inhibition for prevention of stroke after non-cardioembolic stroke or TIA.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov (NCT05686070).</p>","PeriodicalId":46821,"journal":{"name":"European Stroke Journal","volume":"11 1","pages":""},"PeriodicalIF":4.5,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12866625/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146087650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}