NCT00243178|TerminatedPhase 3

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

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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1 other identifier

EFC4912 W

Study Type

interventional

Target

6,706

Locations

31 countries

Sites

Timeline

RegisteredOct 2005

StartedJul 2003

CompletionSep 2005

Brief Summary

The purpose of this study is to determine if the combination of Clopidogrel 75mg once daily (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation therapy with a lower risk of bleeding in patients with atrial fibrillation associated with at least one major cardiovascular risk factor.Primary objectives :The combination of clopidogrel plus aspirin compared to adjusted dose (INR between 2.0 and 3.3) oral anticoagulation (a vitamin K antagonist) will result in the same risk of the composite outcome of stroke, non-CNS systemic embolism, myocardial infarction or vascular death in patients with atrial fibrillation.The secondary objective is to establish whether or not aspirin plus clopidogrel has a lower risk of hemorrhage than standard anticoagulation therapy.

Trial Health

Monitor

Trial Health Score

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

Enrollment

6,706

participants targeted

Target at P75+ for phase_3 atrial-fibrillation

Timeline

Completed

Started Jul 2003

Geographic Reach

31 countries

31 active sites

Status

terminated

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

2.2 years study duration

Study Start

First participant enrolled

July 1, 2003

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2005

Completed

Last Updated

October 19, 2009

Status Verified

October 1, 2009

Enrollment Period

2.2 years

First QC Date

October 20, 2005

Last Update Submit

October 16, 2009

Conditions

Atrial Fibrillation Vascular Risk

Keywords

Atrial fibrillationAnticoagulant therapyThromboembolic prevention

Outcome Measures

Primary Outcomes (1)

Primary outcome:time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death
during approximately three years of follow-up

Secondary Outcomes (1)

Secondary outcomes: major hemorrhage, total mortality and stroke.
during approximately three years of follow-up

Interventions

clopidogrel (SR25990C)DRUG

75 mg once daily in combination with aspirin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Evidence of atrial fibrillation either on one current Electrocardiogram (ECG) or on two ECG recorded at two weeks a part during 6 months prior to study enrollment.
Evidence of high risk of vascular events: at least one of the following risk criteria must be present:
are 75 years or greater;
on treatment for systemic hypertension;
prior stroke, TIA, or non-CNS systemic embolus;
left ventricular dysfunction with left ventricular ejection fraction (EF) estimated by echocardiogram or angiogram (radionuclide or contrast) to be \< 45%;
peripheral vascular disease (previous peripheral artery revascularization, limb and foot amputation, or the combination of current intermittent claudication and ankle arm systolic blood pressure ratio \< 0.9);
age 55 to 74 years; AND
either diabetes mellitus requiring drug therapy, or documented previous myocardial infarction, or documented coronary artery disease.

You may not qualify if:

Patients will be excluded from ACTIVE 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 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; OR
requirement for chronic (\> 3 months) non-COX-2 inhibitor NSAID therapy.

Contact the study team to confirm eligibility.