Phase 3 N=9,016 Randomized Triple-blind Prevention

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

Atrial Fibrillation · Cardiovascular Disease

Bottom Line

View on ClinicalTrials.gov: NCT00249795 ↗

Enrolled (actual)

9,016

Serious AEs

31.7%

Results posted

Oct 2010

Primary outcome: Primary: First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication — 963; 963; 136; 123 participants — p=0.8570

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Irbesartan (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sanofi
Primary completion: Aug 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication	963; 963; 136; 123; 367; 407	0.8570
PRIMARY First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication	1236; 1291; 122; 112; 340; 375	0.1200
SECONDARY First Occurrence of Stroke	379; 411	0.2162
SECONDARY Death From Any Cause	949; 929	0.7590
SECONDARY First Occurrence of Any Heart Failure (HF) Episode	699; 767	0.0369 sig
SECONDARY First Hospitalisation for Heart Failure (HF)	482; 551	0.0175 sig
SECONDARY First Hospitalisation for Other Cardiovascular (CV) Cause	1186; 1174	0.8377

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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 3 months) non-cyclooxygenase-2 (non-COX-2) inhibitor nonsteroidal anti-inflammatory drug (NSAID) therapy unless willing enrolled in ACTIVE A

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00249795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.