PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes: A Double-blind, Active and Placebo Controlled Study of Aggrenox vs. Clopidogrel, With and Without Micardis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20,332
- 试验地点
- 667
- 主要终点
- Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)
研究概览
简要总结
The purpose of the trial is to determine if extended-release dipyridamole + aspirin [Aggrenox, Asasa ntin] is superior to clopidogrel [Plavix], and if telmisartan [Micardis, Gliosartan, Kinzal, Kinzalm ono, Predxal, Pritor, Samertan, Telmisartan] is superior to placebo, in the presence of background antihypertensive therapy, in prevention of a second stroke in patients who have recently suffered a stroke and therefore are at high risk of suffering another one.
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
- Double
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Aggrenox, clop placebo, micardis placebo
Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd
干预措施: Micardis placebo (Drug)
Aggrenox plcebo, clop, micardis placebo
Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.
干预措施: Aggrenox placebo (Drug)
Aggrenox, Clopidogrel placebo, Micardis
Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd
干预措施: Aggrenox (Drug)
Aggrenox, Clopidogrel placebo, Micardis
Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd
干预措施: Clopidogrel placebo (Drug)
Aggrenox, Clopidogrel placebo, Micardis
Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis (80mg) qd
干预措施: Micardis (Drug)
Aggrenox placebo, clopidogrel,, Micardis
Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd
干预措施: Micardis (Drug)
Aggrenox placebo, clopidogrel,, Micardis
Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd
干预措施: Aggrenox placebo (Drug)
Aggrenox placebo, clopidogrel,, Micardis
Clopidogrel (75mg) qd; Aggrenox placebo bid, Micardis (80mg) qd
干预措施: Clopidogrel (Drug)
Aggrenox, clop placebo, micardis placebo
Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd
干预措施: Aggrenox (Drug)
Aggrenox, clop placebo, micardis placebo
Aggrenox (25mg/200mg) bid, clopidogrel placebo qd, Micardis placebo qd
干预措施: Clopidogrel placebo (Drug)
Aggrenox plcebo, clop, micardis placebo
Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.
干预措施: Clopidogrel (Drug)
Aggrenox plcebo, clop, micardis placebo
Clopidogrel (75mg) qd, Aggrenox placebo bid, Micardis placebo qd.
干预措施: Micardis placebo (Drug)
结局指标
主要结局
Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only)
时间窗: time since randomization; follow-up period is 1.5 to 4.4 years
Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only)
时间窗: time since randomization; follow-up period is 1.5 to 4.4 years
次要结局
- Composite Outcome of Stroke, Myocardial Infarction (MI), or Vascular Death (Antiplatelet Comparison Only)(time since randomization; follow-up period is 1.5 to 4.4 years)
- Composite Outcome of Stroke, Myocardial Infarction, Vascular Death, or New or Worsening Congestive Heart Failure (CHF) (Telmisartan vs. Placebo Only)(time since randomization; follow-up period is 1.5 to 4.4 years)
- Number of Patients With New Onset of Diabetes (Telmisartan vs. Placebo Only)(Randomization to final patient contact)