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
- 已完成
- 发起方
- Sanofi
- 入组人数
- 9,016
- 试验地点
- 1
- 主要终点
- First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication
研究概览
简要总结
The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.
详细描述
ACTIVE I was one of the 3 separate but related trials of the ACTIVE program conducted in AF patients at risk of vascular events.
Patients were enrolled first into one of the 2 parallel trials of the ACTIVE program evaluating Clopidogrel:
- ACTIVE A comparing clopidogrel + acetylsalicylic acid (ASA) and ASA alone
- ACTIVE W comparing clopidogrel + ASA and oral anticoagulant (OAC).
Then those satisfying additional criteria related to blood pressure and angiotensin receptor blocking agents were re-randomized in the two ACTIVE I arms according to a separate randomization list.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Should fulfill the eligibility criteria for ACTIVE A or ACTIVE W trial and:
- •have a systolic blood pressure of at least 110 mmHg
- •not already receiving an angiotensin receptor blocking agent, unless they are willing and able to be changed to another antihypertensive agent
- •no previous intolerance to angiotensin receptor blocking agents
- •no proven indication for angiotensin receptor blocking agents, unless an Angiotensin Converting Enzyme (ACE) inhibitor can be substituted
排除标准
- •Patients will be excluded from ACTIVE study 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 acetylsalicyclic acid (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
- •requirement for chronic (> 3 months) non-cyclooxygenase-2 (non-COX-2) inhibitor nonsteroidal anti-inflammatory drug (NSAID) therapy unless willing enrolled in ACTIVE A
研究组 & 干预措施
Irbesartan
150 mg for 2 weeks, then up-titrated to 300 mg up to final follow-up visit
干预措施: Irbesartan (Drug)
Placebo
Matching placebo up to final follow-up visit
干预措施: placebo (Drug)
结局指标
主要结局
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication
时间窗: Median follow-up of 4.5 years
The first co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal) or vascular death - after validation by the Event Adjudication Committee (EAC).
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication
时间窗: Median follow-up of 4.5 years
The second co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal), vascular death or hospitalization for heart failure - after validation by the EAC.
次要结局
- First Occurrence of Stroke(Median follow-up of 4.5 years)
- Death From Any Cause(Median follow-up of 4.5 years)
- First Occurrence of Any Heart Failure (HF) Episode(Median follow-up of 4.5 years)
- First Hospitalisation for Heart Failure (HF)(Median follow-up of 4.5 years)
- First Hospitalisation for Other Cardiovascular (CV) Cause(Median follow-up of 4.5 years)