A Parallel Randomized Controlled Evaluation of Clopidogrel Plus Aspirin, With Factorial Evaluation of Irbesartan, for the Prevention of Vascular Events, in Patients With Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 6,706
- 试验地点
- 32
- 主要终点
- Primary outcome:time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death
研究概览
简要总结
The purpose of this study is to determine if the combination of Clopidogrel 75mg once daily (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation therapy with a lower risk of bleeding in patients with atrial fibrillation associated with at least one major cardiovascular risk factor.Primary objectives :The combination of clopidogrel plus aspirin compared to adjusted dose (INR between 2.0 and 3.3) oral anticoagulation (a vitamin K antagonist) will result in the same risk of the composite outcome of stroke, non-CNS systemic embolism, myocardial infarction or vascular death in patients with atrial fibrillation.The secondary objective is to establish whether or not aspirin plus clopidogrel has a lower risk of hemorrhage than standard anticoagulation therapy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of atrial fibrillation either on one current Electrocardiogram (ECG) or on two ECG recorded at two weeks a part during 6 months prior to study enrollment.
- •Evidence of high risk of vascular events: at least one of the following risk criteria must be present:
- •are 75 years or greater;
- •on treatment for systemic hypertension;
- •prior stroke, TIA, or non-CNS systemic embolus;
- •left ventricular dysfunction with left ventricular ejection fraction (EF) estimated by echocardiogram or angiogram (radionuclide or contrast) to be < 45%;
- •peripheral vascular disease (previous peripheral artery revascularization, limb and foot amputation, or the combination of current intermittent claudication and ankle arm systolic blood pressure ratio < 0.9);
- •age 55 to 74 years; AND
- •either diabetes mellitus requiring drug therapy, or documented previous myocardial infarction, or documented coronary artery disease.
排除标准
- •Patients will be excluded from ACTIVE if any of the following are present :
- •requirement for clopidogrel (such as recent coronary stent procedure);
- •requirement for oral anticoagulant (such as prosthetic mechanical heart valve);
- •prior intolerance to ASA or clopidogrel;
- •documented peptic ulcer disease within the previous 6 months;
- •prior intracerebral hemorrhage;
- •significant thrombocytopenia; (platelet count < 50 x 10(9)/L);
- •psychosocial reason making study participation impractical;
- •geographic reason making study participation impractical;
- •ongoing alcohol abuse;
- •mitral stenosis;
- •pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study;
- •severe comorbid condition such that the patient is not expected to survive 6 months;
- •patient currently receiving an investigational pharmacologic agent; OR
- •requirement for chronic (> 3 months) non-COX-2 inhibitor NSAID therapy.
结局指标
主要结局
Primary outcome:time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death
时间窗: during approximately three years of follow-up
次要结局
- Secondary outcomes: major hemorrhage, total mortality and stroke.(during approximately three years of follow-up)