Trial record 1 of 2 for: ACTIVE-W

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

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ClinicalTrials.gov Identifier: NCT00243178

Recruitment Status : Terminated

First Posted : October 21, 2005

Last Update Posted : October 19, 2009

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by:

Sanofi

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation Vascular Risk	Drug: clopidogrel (SR25990C)	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	6706 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	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
Study Start Date :	July 2003
Actual Primary Completion Date :	September 2005
Actual Study Completion Date :	September 2005

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Clopidogrel Clopidogrel bisulfate

U.S. FDA Resources

Arms and Interventions

Intervention Details:

Drug: clopidogrel (SR25990C)
75 mg once daily in combination with aspirin

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243178

Locations

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Australia
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Austria
Sanofi-Aventis Administrative Office
Wien, Austria
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Denmark
Sanofi-Aventis Administrative Office
Horsholm, Denmark
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Greece
Sanofi-Aventis Administrative Office
Athens, Greece
Hong Kong
Sanofi-Aventis Administrative Office
Causeway Bay, Hong Kong
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Israel
Sanofi-Aventis Administrative Office
Natanya, Israel
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Norway
Sanofi-Aventis Administrative Office
Lysaker, Norway
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Singapore
Sanofi-Aventis Administrative Office
Singapore, Singapore
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom

Sponsors and Collaborators

Sanofi

Bristol-Myers Squibb

Investigators

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Study Chair:	Salim YUSUF, Prof.	Hamilton Health Sciences Corporation

More Information

Publications of Results:

ACTIVE Writing Group of the ACTIVE Investigators; Connolly S, Pogue J, Hart R, Pfeffer M, Hohnloser S, Chrolavicius S, Pfeffer M, Hohnloser S, Yusuf S. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial. Lancet. 2006 Jun 10;367(9526):1903-12. doi: 10.1016/S0140-6736(06)68845-4.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Flaker GC, Pogue J, Yusuf S, Pfeffer MA, Goldhaber SZ, Granger CB, Anand IS, Hart R, Connolly SJ; Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE) Investigators. Cognitive function and anticoagulation control in patients with atrial fibrillation. Circ Cardiovasc Qual Outcomes. 2010 May;3(3):277-83. doi: 10.1161/CIRCOUTCOMES.109.884171. Epub 2010 Mar 16.

Cairns JA, Wittes J, Wyse DG, Pogue J, Gent M, Hirsh J, Marler J, Pritchett EL. Monitoring the ACTIVE-W trial: some issues in monitoring a noninferiority trial. Am Heart J. 2008 Jan;155(1):33-41. doi: 10.1016/j.ahj.2007.09.011. Epub 2007 Nov 26.

Hohnloser SH, Pajitnev D, Pogue J, Healey JS, Pfeffer MA, Yusuf S, Connolly SJ; ACTIVE W Investigators. Incidence of stroke in paroxysmal versus sustained atrial fibrillation in patients taking oral anticoagulation or combined antiplatelet therapy: an ACTIVE W Substudy. J Am Coll Cardiol. 2007 Nov 27;50(22):2156-61. doi: 10.1016/j.jacc.2007.07.076. Epub 2007 Nov 13.

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Responsible Party:	ICD Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00243178
Other Study ID Numbers:	EFC4912 W
First Posted:	October 21, 2005 Key Record Dates
Last Update Posted:	October 19, 2009
Last Verified:	October 2009

Keywords provided by Sanofi:


Atrial fibrillation Anticoagulant therapy Thromboembolic prevention

Additional relevant MeSH terms:

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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Clopidogrel Platelet Aggregation Inhibitors	Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

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