NCT00862420已完成3 期
A Randomized, Double Blind, Parallel Group Study to Investigate the Safety of 12 Weeks of Clopidogrel 75 mg/Day Versus Ticlopidine 200 mg/Day in Patients With Peripheral Arterial Disease - With Extended Treatment of Clopidogrel 75 mg/Day for 40 Weeks
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 431
- 试验地点
- 1
- 主要终点
- Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...)
研究概览
简要总结
Primary objective:
- To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interests in patients with peripheral arterial disease (PAD)
Secondary objectives:
- To compare the risk of bleeding adverse events, serious adverse events and overall safety of clopidogrel with ticlopidine
- To compare the risk of vascular events of clopidogrel with ticlopidine
- To document the long-term safety of clopidogrel for a total of 52 weeks
- To document the vascular events of clopidogrel for a total of 52 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented symptomatic peripheral arterial disease (one or both of the following two primary criteria must be satisfied):
- •Current intermittent claudication with Ankle Brachial Index (ABI) < 0.90
- •A history of intermittent claudication together with previous related intervention in a leg
排除标准
- •Patients who had acute atherothrombotic events or any invasive therapies within 30 days before the randomization, or patients who planned any invasive therapies within 12 weeks after the randomization
- •Bleeding diathesis, coagulopathy and present bleeding disease
- •Previous intracranial bleeding or hemorrhagic stroke
- •Uncontrolled hypertension
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Clopidogrel
Experimental
75 mg clopidogrel once daily from Day 1 to Week 12
干预措施: clopidogrel (SR25990) (Drug)
Ticlopidine
Active Comparator
200 mg ticlopidine once daily from Day 1 to Week 12
干预措施: ticlopidine (Drug)
结局指标
主要结局
Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...)
时间窗: Week 12 (on treatment)
次要结局
- Vascular events(Week 12, 52 (on study))
- Safety events of interest (see above)(Week 52 (on treatment))
- Bleeding adverse events, Serious adverse events, Overall safety(Week 12, 52 (on treatment))
研究者
研究点 (1)
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