Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I) "ACTIVE I"

Completed

Phase 3 Results

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • 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

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of two arms: Irbesartan oral administration of 300mg once daily or placebo once daily oral.

Outcomes

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

Sponsors