Effect of PCSK9 inhibitor on early neurological deterioration in acute ischemic stroke patients with a history of coronary heart disease: a study protocol for a randomized controlled trial in Dalian, China.
Xing Gong, Xinting Yu, Lanlan Pu, Yang Jiao, Lin Liu, Hua Cao, Xiaofei Ji
{"title":"Effect of PCSK9 inhibitor on early neurological deterioration in acute ischemic stroke patients with a history of coronary heart disease: a study protocol for a randomized controlled trial in Dalian, China.","authors":"Xing Gong, Xinting Yu, Lanlan Pu, Yang Jiao, Lin Liu, Hua Cao, Xiaofei Ji","doi":"10.1186/s13063-024-08709-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Early neurological deterioration (END) is a critical determinant influencing the short-term prognosis of acute ischemic stroke (AIS) patients and is associated with increased mortality rates among hospitalized individuals. AIS frequently coexists with coronary heart disease (CHD), complicating treatment and leading to more severe symptoms and worse outcomes. Shared risk factors between CHD and AIS, especially elevated low-density lipoprotein cholesterol (LDL-C), contribute to atherosclerosis and inflammation, which worsen brain tissue damage. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors offer a promising treatment option. They effectively lower LDL-C levels and may help reduce END in AIS patients with CHD. This study aims to evaluate how effective PCSK9 inhibitors are in reducing END among this high-risk group and to provide new insights for treatment strategies.</p><p><strong>Methods: </strong>This is a prospective, randomized, parallel-group, blinded-endpoint, single-center clinical study. A total of 156 AIS patients with a history of CHD and within 24 h from symptom onset will be recruited and randomized in a 1:1 allocation to either the PCSK9 inhibitor combined with statin treatment group (PI group) or the statin monotherapy group (AT group). The PI group will receive a combination therapy consisting of evolocumab and rosuvastatin calcium tablets, while the AT group will receive only oral rosuvastatin calcium tablets. The trial duration will last for 90 days and comprise three phases: screening, treatment intervention, and follow-up assessments. Participants will undergo comprehensive examinations and assessments on days 1, 7, 30, and 90 after enrollment.</p><p><strong>Discussion: </strong>This study aims to investigate the potential preventive effects of PCSK9 inhibitors on END in AIS patients with a history of CHD. A positive outcome from this trial could provide novel clinical strategies for reducing the incidence of END and improving the short-term prognosis among these stroke patients.</p><p><strong>Trial registration: </strong>China Clinical Trial Registry, ChiCTR2300078198. Registered on 30 November 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"7"},"PeriodicalIF":2.0000,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11702183/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Trials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13063-024-08709-2","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Early neurological deterioration (END) is a critical determinant influencing the short-term prognosis of acute ischemic stroke (AIS) patients and is associated with increased mortality rates among hospitalized individuals. AIS frequently coexists with coronary heart disease (CHD), complicating treatment and leading to more severe symptoms and worse outcomes. Shared risk factors between CHD and AIS, especially elevated low-density lipoprotein cholesterol (LDL-C), contribute to atherosclerosis and inflammation, which worsen brain tissue damage. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors offer a promising treatment option. They effectively lower LDL-C levels and may help reduce END in AIS patients with CHD. This study aims to evaluate how effective PCSK9 inhibitors are in reducing END among this high-risk group and to provide new insights for treatment strategies.
Methods: This is a prospective, randomized, parallel-group, blinded-endpoint, single-center clinical study. A total of 156 AIS patients with a history of CHD and within 24 h from symptom onset will be recruited and randomized in a 1:1 allocation to either the PCSK9 inhibitor combined with statin treatment group (PI group) or the statin monotherapy group (AT group). The PI group will receive a combination therapy consisting of evolocumab and rosuvastatin calcium tablets, while the AT group will receive only oral rosuvastatin calcium tablets. The trial duration will last for 90 days and comprise three phases: screening, treatment intervention, and follow-up assessments. Participants will undergo comprehensive examinations and assessments on days 1, 7, 30, and 90 after enrollment.
Discussion: This study aims to investigate the potential preventive effects of PCSK9 inhibitors on END in AIS patients with a history of CHD. A positive outcome from this trial could provide novel clinical strategies for reducing the incidence of END and improving the short-term prognosis among these stroke patients.
Trial registration: China Clinical Trial Registry, ChiCTR2300078198. Registered on 30 November 2023.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
