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近期发生短暂性脑缺血发作或缺血性卒中的高危患者使用氯吡格雷治疗动脉粥样硬化血栓形成(MATCH):研究设计与基线数据

Management of atherothrombosis with clopidogrel in high-risk patients with recent transient ischaemic attack or ischaemic stroke (MATCH): study design and baseline data.

作者信息

Diener Hans-Christoph, Bogousslavsky Julien, Brass Lawrence M, Cimminiello Claudio, Csiba Laszlo, Kaste Markku, Leys Didier, Matias-Guiu Jordi, Rupprecht Hans-Jürgen

机构信息

Department of Neurology, University of Essen, Germany.

出版信息

Cerebrovasc Dis. 2004;17(2-3):253-61. doi: 10.1159/000076962. Epub 2004 Feb 23.

Abstract

BACKGROUND

The CAPRIE study showed the superiority of clopidogrel over acetylsalicylic acid (ASA) for reducing the combined risk of major atherothrombotic events in patients with recent myocardial infarction (MI), recent ischaemic stroke (IS) or established peripheral arterial disease. The benefit of clopidogrel over ASA is amplified in high-risk patients. Proof of concept for the benefit of clopidogrel in addition to ASA in patients with coronary manifestations of atherothrombosis was provided by the CURE trial.

METHODS

MATCH is a randomized, double-blind, placebo-controlled trial that compares clopidogrel and ASA versus clopidogrel alone in high-risk patients with recently symptomatic cerebrovascular disease. Eligible patients have experienced a transient ischaemic attack (TIA) or IS within the last 3 months and have evidence of at least 1 additional risk factor within the last 3 years (prior IS, MI, stable or unstable angina pectoris, diabetes or symptomatic peripheral arterial disease). Patients were randomized to receive ASA 75 mg once daily or placebo, with both groups receiving clopidogrel 75 mg once daily as part of standard therapy. The primary end point is the composite of IS, MI, vascular death and rehospitalization for an acute ischaemic event. The duration of treatment and follow-up is 18 months for each patient.

RESULTS

Enrollment was completed in April 2002, with 7,599 patients randomized to receive the study medication. The mean age at randomization was 66 years, and the qualifying event was IS in 78.9% of patients and TIA in 21.1%. The baseline features of the study cohort indicate a population that is at a high risk for atherothrombotic recurrence.

CONCLUSION

MATCH is a major ongoing trial that will provide important data on the benefit of clopidogrel and ASA compared with clopidogrel alone for reduction of vascular ischaemic events in patients with recent TIA or IS who are at high risk of atherothrombotic event recurrence.

摘要

背景

CAPRIE研究表明,在降低近期心肌梗死(MI)、近期缺血性卒中(IS)或已确诊外周动脉疾病患者的主要动脉粥样硬化血栓形成事件的综合风险方面,氯吡格雷优于阿司匹林(ASA)。在高危患者中,氯吡格雷相对于ASA的益处更为显著。CURE试验提供了证据,证明在有动脉粥样硬化血栓形成冠状动脉表现的患者中,除ASA外使用氯吡格雷有益。

方法

MATCH是一项随机、双盲、安慰剂对照试验,比较氯吡格雷与ASA联合用药和单独使用氯吡格雷在近期有症状性脑血管疾病的高危患者中的疗效。符合条件的患者在过去3个月内经历过短暂性脑缺血发作(TIA)或IS,且在过去3年内有至少1项其他危险因素(既往IS、MI、稳定或不稳定型心绞痛、糖尿病或有症状的外周动脉疾病)的证据。患者被随机分为接受每日1次75 mg ASA或安慰剂,两组均接受每日1次75 mg氯吡格雷作为标准治疗的一部分。主要终点是IS、MI、血管性死亡和因急性缺血事件再次住院的复合终点。每位患者的治疗和随访时间为18个月。

结果

2002年4月完成入组,7599例患者被随机分配接受研究药物治疗。随机分组时的平均年龄为66岁,78.9%的患者符合事件为IS,21.1%为TIA。研究队列的基线特征表明该人群有动脉粥样硬化血栓形成复发的高风险。

结论

MATCH是一项正在进行的重要试验,将提供重要数据,以比较氯吡格雷与ASA联合用药和单独使用氯吡格雷在近期TIA或IS且有动脉粥样硬化血栓形成事件复发高风险患者中减少血管缺血事件的益处。

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