TICA-CLOP STUDY: Ticagrelor Versus Clopidogrel in Acute Moderate and Moderate-to-Severe Ischemic Stroke, a Randomized Controlled Multi-Center Trial.

IF 7.4 2区医学 Q1 CLINICAL NEUROLOGY CNS drugs Pub Date : 2024-11-09 DOI:10.1007/s40263-024-01127-7

Sherihan Rezk Ahmed, Nevine El Nahas, Mohamed Fouad Elsayed Khalil, Ahmed Elbassiouny, Mohamed Ahmed Almoataz, Tarek Youssif Omar, Ahmed Mohamed Ali Daabis, Hossam Mohamed Refat, Ahmed Ahmed Mohamed Kamal Ebied, Asmaa Mohammed Hassan, Diaa Mostafa Atiaa Mohamed, Mohamed Ismaiel, Mohamed G Zeinhom

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Abstract

Background: Many studies evaluated the efficacy and safety of ticagrelor versus clopidogrel in patients with ischemic stroke; none of these trials included North African participants, and all of these trials comprised only participants who experienced transient ischemic attack (TIA) or minor stroke.

Objectives: We compared the efficacy and safety of ticagrelor versus clopidogrel in patients with first-ever noncardioembolic moderate or moderate-to-severe ischemic stroke.

Methods: Our trial involved 900 first-ever noncardioembolic patients with acute ischemic stroke (AIS) who randomly received either loading and maintenance doses of ticagrelor or clopidogrel within the first 24 h of stroke onset.

Results: We involved 900 patients in the intention-to-treat analysis. A total of 39 (8.7%) patients in ticagrelor arm and 62 (13.8%) in clopidogrel arm experienced a new stroke [hazard ratio (HR) 0.46; 95% confidence interval (CI) 0.34-0.83; P value = 0.006]. A total of 57 (12.7%) patients in ticagrelor group and 80 (17.8%) patients in clopidogrel group experienced composite of new stroke, myocardial infarction (MI), or death due to vascular insults (HR 0.51; 95% CI 0.43-0.82; P value = 0.004). Participants who received ticagrelor experienced less frequent unfavorable outcomes. We found no significant variation between our study's two arms concerning the hemorrhagic and non-hemorrhagic complications.

Conclusion: Patients with noncardioembolic moderate or moderate-to-severe ischemic stroke who received ticagrelor within the first 24 h after ischemic stroke had better clinical outcomes based on recurrent stroke rates and unfavorable modified Rankin Scale (mRS) rates compared with those who received clopidogrel. There were no significant variations between ticagrelor and clopidogrel regarding hemorrhagic and non-hemorrhagic complications.

Registration: ClinicalTrials.gov identifier number NCT05553613.

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TICA-CLOP研究：Ticagrelor与氯吡格雷治疗急性中度和中重度缺血性卒中的多中心随机对照试验。

背景：许多研究评估了替卡格雷与氯吡格雷在缺血性卒中患者中的疗效和安全性；这些试验均未纳入北非参与者，而且所有这些试验的参与者均为短暂性脑缺血发作（TIA）或轻微卒中患者：我们比较了替卡格雷与氯吡格雷对首次非心肌栓塞中度或中重度缺血性卒中患者的疗效和安全性：我们的试验涉及 900 名首次非心肌栓塞急性缺血性卒中（AIS）患者，他们在卒中发生后 24 小时内随机接受负荷和维持剂量的替卡格雷或氯吡格雷：我们对 900 名患者进行了意向治疗分析。共有 39 例（8.7%）服用替卡格雷的患者和 62 例（13.8%）服用氯吡格雷的患者发生了新的中风[危险比 (HR) 0.46; 95% 置信区间 (CI) 0.34-0.83; P 值 = 0.006]。替卡格雷组共有 57 例（12.7%）患者，氯吡格雷组共有 80 例（17.8%）患者出现新发中风、心肌梗死或因血管损伤死亡的复合情况（HR 0.51；95% CI 0.43-0.82；P 值 = 0.004）。接受替卡格雷治疗的参试者发生不良后果的频率较低。我们发现，在出血和非出血并发症方面，研究的两个臂之间没有明显差异：结论：与接受氯吡格雷治疗的患者相比，在缺血性脑卒中发生后 24 小时内接受替卡格雷治疗的非心肌栓塞中度或中重度缺血性脑卒中患者，根据脑卒中复发率和改良Rankin量表（mRS）不良率计算，临床预后更好。在出血性和非出血性并发症方面，替卡格雷和氯吡格雷之间没有明显差异：注册：ClinicalTrials.gov 识别号 NCT05553613。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

CNS drugs 医学-精神病学

CiteScore

12.00

自引率

3.30%

发文量

审稿时长

6-12 weeks

期刊介绍： CNS Drugs promotes rational pharmacotherapy within the disciplines of clinical psychiatry and neurology. The Journal includes: - Overviews of contentious or emerging issues. - Comprehensive narrative reviews that provide an authoritative source of information on pharmacological approaches to managing neurological and psychiatric illnesses. - Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. - Adis Drug Reviews of the properties and place in therapy of both newer and established drugs in neurology and psychiatry. - Original research articles reporting the results of well-designed studies with a strong link to clinical practice, such as clinical pharmacodynamic and pharmacokinetic studies, clinical trials, meta-analyses, outcomes research, and pharmacoeconomic and pharmacoepidemiological studies. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in CNS Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.