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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Atrial Fibrillation

Cardiovascular Disease

Treatments

Drug: Irbesartan

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00249795

EFC4912 I

Clopidogrel (SR25990)

Details and patient eligibility

About

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.

Full 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.

Enrollment

9,016 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 <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