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.
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.
- Placebo Drug
Intervention Desc: oral administration (tablets) once daily ARM 1: Kind: Experimental Label: Placebo Description: Matching placebo up to final follow-up visit
- irbesartan (AVAPRO®*)Drug
Other Names: Aprovel® Intervention Desc: oral administration (tablets) once daily ARM 1: Kind: Experimental Label: Irbesartan Description: 150 mg for 2 weeks, then up-titrated to 300 mg up to final follow-up visit
- Allocation: Randomized
- Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
- Purpose: Prevention
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
Patients will be randomized to one of two arms: Irbesartan oral administration of 300mg once daily or placebo once daily oral.
|Type||Measure||Time Frame||Safety Issue|
|Primary||First composite outcome of stroke, myocardial infarction or vascular death. Second composite outcome of stroke, myocardial infarction, vascular death or hospitalization for heart failure.|
|Secondary||Total mortality, stroke, hospitalization for heart failure and other heart failure episodes defined as evidence of symptoms or signs of heart failure (with or without hospitalization).|
|Primary||First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication||Median follow-up of 4.5 years||No|
|Primary||First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication||Median follow-up of 4.5 years||No|
|Secondary||First Occurrence of Stroke||Median follow-up of 4.5 years||No|
|Secondary||Death From Any Cause||Median follow-up of 4.5 years||No|
|Secondary||First Occurrence of Any Heart Failure (HF) Episode||Median follow-up of 4.5 years||No|
|Secondary||First Hospitalisation for Heart Failure (HF)||Median follow-up of 4.5 years||No|
|Secondary||First Hospitalisation for Other Cardiovascular (CV) Cause||Median follow-up of 4.5 years||No|