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

Sanofi9,016 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

9,016

Conditions

Atrial Fibrillation Cardiovascular Disease

Interventions

IrbesartanDRUG

oral administration (tablets) once daily

placeboDRUG

oral administration (tablets) once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (30)

Outcomes

Primary Outcomes

First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication

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).

Time frame: Median follow-up of 4.5 years

First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication

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.

Time frame: Median follow-up of 4.5 years

Secondary Outcomes

First Occurrence of Stroke

The considered event is the first occurrence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) over the duration of follow-up, after validation by the EAC.

Time frame: Median follow-up of 4.5 years

Death From Any Cause

The considered event is the death over the duration of the follow-up whatever the cause, cardiovascular or non-cardiovascular.

Time frame: Median follow-up of 4.5 years

First Occurrence of Any Heart Failure (HF) Episode

The considered event is the first occurence of any HF episode defined as evidence of signs and symptoms of HF with or without hospitalization over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).

Time frame: Median follow-up of 4.5 years

Data from ClinicalTrials.gov

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