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首页> 美国卫生研究院文献>Annals of Vascular Diseases >Clopidogrel for Atherothrombotic Event Management in Patients with Peripheral Arterial Disease (COOPER) Study: Safety and Efficacy of Clopidogrel versus Ticlopidine in Japanese Patients
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Clopidogrel for Atherothrombotic Event Management in Patients with Peripheral Arterial Disease (COOPER) Study: Safety and Efficacy of Clopidogrel versus Ticlopidine in Japanese Patients

机译：氯吡格雷用于外周动脉疾病患者的血栓栓塞事件管理（COOPER）研究：氯吡格雷与噻氯匹定在日本患者中的安全性和有效性

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Background: Peripheral arterial disease (PAD) has been recognized as an independent risk factor for vascular events and contributes to an adverse prognosis. Long-term administration of clopidogrel is recommended to prevent atherothrombotic events for patients with established PAD. We investigated the benefits of clopidogrel treatment in Japanese patients with PAD.Materials and Methods: COOPER (Clopidogrel for atherOthrombOtic event management in patients with PERipheral arterial disease) was a multicenter, randomized, double-blind study to evaluate the safety and efficacy of clopidogrel (75 mg/day) compared to ticlopidine (200 mg/day) in Japanese patients with PAD. The primary endpoint was the cumulative incidence of “safety events of interest” comprising clinically significant bleeding, blood disorders, hepatic dysfunction and other serious adverse events up to 12 weeks. The other safety events and vascular events were also assessed. Patients were followed up to 52 weeks.Results: A total of 431 patients with PAD were randomly assigned to receive either clopidogrel or ticlopidine. The cumulative incidences of “safety events of interest” at 12 weeks were 2.4% and 13.6% of patients who received clopidogrel and ticlopidine, respectively (adjusted hazard ratio, 0.161; 95% confidence interval, 0.062 to 0.416; p <0.0001). Bleeding and vascular events were similar in both groups.Conclusion: Clopidogrel demonstrated a favorable benefit/risk profile than ticlopidine in Japanese patients with PAD.(Trial registration: ClinicalTrials.gov, Identifier: )
机译：背景：周围动脉疾病（PAD）已被认为是血管事件的独立危险因素，并有助于不良预后。建议长期服用氯吡格雷，以防止已建立PAD的患者发生动脉粥样硬化性血栓形成事件。我们研究了氯吡格雷对日本PAD患者的治疗益处。材料与方法：COOPER（氯吡格雷用于外周动脉疾病患者的动脉粥样硬化事件管理）是一项多中心，随机，双盲研究，旨在评估氯吡格雷（安全性和有效性） 75毫克/天）与噻氯匹定（200毫克/天）相比于日本PAD患者。主要终点是“感兴趣的安全事件”的累积发生率，包括临床上显着的出血，血液疾病，肝功能障碍和其他严重不良事件，直至12周。还评估了其他安全事件和血管事件。患者接受了长达52周的随访。结果：共有431名PAD患者被随机分配接受氯吡格雷或噻氯匹定治疗。接受氯吡格雷和噻氯匹定治疗的患者在12周时的“相关安全事件”累积发生率分别为2.4％和13.6％（调整后的危险比为0.161； 95％的置信区间为0.062至0.416； p <0.0001）。两组的出血和血管事件相似。结论：氯吡格雷在日本PAD患者中显示出比噻氯匹定更好的获益/风险（试验注册：ClinicalTrials.gov，标识：）

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