NCT00249795|CompletedPhase 3ResultsDMC

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

ACTIVE I

A Parallel Randomized Controlled Evaluation of Clopidogrel Plus Aspirin, With Factorial Evaluation of Irbesartan, for the Prevention of Vascular Events, in Patients With Atrial Fibrillation

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC4912 IClopidogrel (SR25990)

Study Type

interventional

Target

9,016

Locations

29 countries

Sites

Timeline

RegisteredNov 2005

StartedJun 2003

CompletionAug 2009

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

9,016

participants targeted

Target at P75+ for phase_3 atrial-fibrillation

Timeline

Completed

Started Jun 2003

Longer than P75 for phase_3 atrial-fibrillation

Geographic Reach

29 countries

29 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.2 years study duration

Study Start

First participant enrolled

June 1, 2003

Completed

2.4 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

October 15, 2010

Completed

Last Updated

October 15, 2010

Status Verified

September 1, 2010

Enrollment Period

6.2 years

First QC Date

November 4, 2005

Results QC Date

August 24, 2010

Last Update Submit

September 29, 2010

Conditions

Atrial Fibrillation Cardiovascular Disease

Keywords

Atrial fibrillationCardiovascular diseaseangiotensin II blocker

Outcome Measures

Primary Outcomes (2)

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).
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.
Median follow-up of 4.5 years

Secondary Outcomes (5)

First Occurrence of Stroke
Median follow-up of 4.5 years
Death From Any Cause
Median follow-up of 4.5 years
First Occurrence of Any Heart Failure (HF) Episode
Median follow-up of 4.5 years
First Hospitalisation for Heart Failure (HF)
Median follow-up of 4.5 years
First Hospitalisation for Other Cardiovascular (CV) Cause
Median follow-up of 4.5 years

Study Arms (2)

Irbesartan

EXPERIMENTAL

150 mg for 2 weeks, then up-titrated to 300 mg up to final follow-up visit

Drug: Irbesartan

Placebo

PLACEBO COMPARATOR

Matching placebo up to final follow-up visit

Drug: placebo

Interventions

IrbesartanDRUG

oral administration (tablets) once daily

Also known as: Aprovel®

Irbesartan

placeboDRUG

oral administration (tablets) once daily

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.