Ticagrelor Versus Clopidogrel in Acute Large-Vessel Ischemic Stroke: A Randomized Controlled Single-Blinded Trial

IF 7.4 2区医学 Q1 CLINICAL NEUROLOGY CNS drugs Pub Date : 2024-04-15 DOI:10.1007/s40263-024-01080-5

Mohamed G. Zeinhom, Ahmed Elbassiouny, Ahmed Mahmoud Mohamed, Sherihan Rezk Ahmed

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Abstract

Background

Large-vessel ischemic stroke represents about 25–40% of all ischemic strokes. Few clinical trials compared ticagrelor versus clopidogrel in ischemic stroke patients; all these studies included only patients with a transient ischemic attack or minor stroke; moreover, none of these studies included patients from North Africa.

Objectives

We aimed to compare ticagrelor versus clopidogrel in the first-ever large-vessel occlusion (LVO) acute ischemic stroke in Egypt.

Methods

Our trial involved 580 first-ever LVO ischemic stroke patients who were randomly assigned to administer loading and maintenance doses of ticagrelor or clopidogrel. Screening, randomization, and start of treatment occurred during the first 24 hours of the stroke.

Results

580 patients were included in the intention-to-treat analysis. Thirty patients in the ticagrelor group and 49 patients in the clopidogrel group experienced a new ischemic or hemorrhagic stroke at 90 days (hazard ratio [HR] 0.61; 95% confidence interval [CI] 0.38–0.98; p-value = 0.04), 36 patients in the ticagrelor group, and 57 in the clopidogrel group experienced composite of a new stroke, myocardial infarction, or death due to vascular insults (HR 0.56; 95% CI 0.37–0.87; p = 0.009). Patients who received ticagrelor had better clinical outcomes regarding National Institutes of Health Stroke Scale (NIHSS) reduction and a favorable modified Rankin scale (mRS) score. There were no differences between ticagrelor and clopidogrel regarding hemorrhagic and non-hemorrhagic complications.

Conclusion

Patients with acute large-vessel ischemic stroke who received ticagrelor within the first 24 hours after ischemic stroke had better clinical outcomes based on recurrent stroke rates, NIHSS reduction, and favorable mRS rates compared with those who received clopidogrel. There were no differences between ticagrelor and clopidogrel regarding hemorrhagic and non-hemorrhagic complications.

Trial Registration

Clinical trials.gov (NCT06120725).

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替卡格雷与氯吡格雷治疗急性大血管缺血性卒中：单盲随机对照试验

背景大血管缺血性卒中约占所有缺血性卒中的 25-40%。很少有临床试验对缺血性卒中患者进行替卡格雷与氯吡格雷的比较；所有这些研究都只纳入了短暂性脑缺血发作或轻微卒中患者；此外，这些研究都没有纳入北非患者。我们的试验涉及 580 名首次发生大血管闭塞（LVO）的缺血性卒中患者，他们被随机分配服用负荷和维持剂量的替卡格雷或氯吡格雷。筛选、随机分配和开始治疗均在中风发生后的 24 小时内进行。噻格瑞洛组和氯吡格雷组分别有 30 名和 49 名患者在 90 天后发生新的缺血性或出血性脑卒中（危险比 [HR] 0.61；95% 置信区间 [CI]0.38-0.98；P 值 = 0.04），接受替卡格雷治疗的患者中有36人出现新发中风、心肌梗死或因血管损伤死亡的复合情况，而接受氯吡格雷治疗的患者中有57人（HR 0.56; 95% CI 0.37-0.87; p = 0.009）。接受替卡格雷治疗的患者在美国国立卫生研究院卒中量表（NIHSS）降低和改良Rankin量表（mRS）评分方面的临床疗效更好。结论与接受氯吡格雷治疗的急性大血管缺血性卒中患者相比，在缺血性卒中发生后 24 小时内接受替卡格雷治疗的急性大血管缺血性卒中患者在卒中复发率、NIHSS 降低率和良好的 mRS 评分方面具有更好的临床预后。在出血性和非出血性并发症方面，ticagrelor和氯吡格雷没有差异。试验注册Clinical trials.gov (NCT06120725)。

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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.