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

NCT ID: NCT00249873

Last Updated: 2015-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 7554 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2009-03-31

Brief Summary

The purpose of this study is to determine if the combination of clopidogrel 75mg once daily (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily recommended dose) for preventing vascular events such as stroke and heart attack during approximately three years of follow-up in patients with atrial fibrillation associated with at least one major risk factor of vascular event such as elderly, blood pressure increase, history of stroke or transient ischemic attack or left ventricular dysfunction etc. The study will also accept patients with atrial fibrillation and unwilling to take oral anticoagulant therapy.

Conditions

Atrial Fibrillation; Vascular Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Clopidogrel + ASA

Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)

Group Type: EXPERIMENTAL

clopidogrel (SR25990C)

Intervention Type: DRUG

oral administration (tablets)

Placebo + ASA

Matching placebo of clopidogrel 75 mg od plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

oral administration (tablets)

Interventions

clopidogrel (SR25990C)

oral administration (tablets)

Intervention Type: DRUG

placebo

oral administration (tablets)

Intervention Type: DRUG

Other Intervention Names

Plavix®

Eligibility Criteria

Inclusion Criteria

To be eligible for ACTIVE A patients must have in same time the three following conditions :

• Evidence of atrial fibrillation either on one current Electrocardiogram (ECG) or two ECGs 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 greater;
• on treatment for systemic hypertension;
• prior stroke, Transient Ischemic Attack (TIA) or non-Central Nervous System (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; f1) diabetes mellitus requiring drug therapy, or f2) documented previous myocardial infarction or documented coronary artery disease.
• To have either a contraindication to use an oral anticoagulant treatment or they are unwilling to take an oral anticoagulant treatment.

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe YUSUF, Prof.

Role: STUDY_CHAIR

Hamilton Health Sciences Corporation

Locations

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Buenos Aires, , Argentina

Sanofi-Aventis Administrative Office

Macquarie Park, , Australia

Sanofi-Aventis

Vienna, , Austria

Sanofi-aventis Administrative Office

Diegem, , Belgium

Sanofi-Aventis Administrative Office

São Paulo, , Brazil

Sanofi-Aventis Administrative Office

Laval, , Canada

Sanofi-Aventis Administrative Office

Santiago, , Chile

Sanofi-Aventis Administrative Office

Prague, , Czechia

Sanofi-Aventis Administrative Office

Hørsholm, , Denmark

Sanofi-Aventis Administrative Office

Helsinki, , Finland

Sanofi-Aventis Administrative Office

Paris, , France

Sanofi-Aventis Administrative Office

Berlin, , Germany

Sanofi-Aventis Administrative Office

Athens, , Greece

Sanofi-Aventis Administrative Office

Causeway Bay, , Hong Kong

Sanofi-Aventis Administrative Office

Budapest, , Hungary

Sanofi-Aventis Administrative Office

Milan, , Italy

Sanofi-Aventis Administrative Office

Kuala Lumpur, , Malaysia

Sanofi-Aventis Administrative Office

México, , Mexico

Sanofi-Aventis Administrative Office

Gouda, , Netherlands

Sanofi-Aventis Administrative Office

Lysaker, , Norway

Sanofi-Aventis Administrative Office

Warsaw, , Poland

Sanofi-Aventis Administrative Office

Porto Salvo, , Portugal

Sanofi-Aventis Administrative Office

Singapore, , Singapore

Sanofi-Aventis Administrative Office

Midrand, , South Africa

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Sanofi-Aventis Administrative Office

Bromma, , Sweden

Sanofi-Aventis Administrative Office

Geneva, , Switzerland

Sanofi-Aventis Administrative Office

Taipei, , Taiwan

Sanofi-Aventis Administrative Office

Guildford Surrey, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Chile; Czechia; Denmark; Finland; France; Germany; Greece; Hong Kong; Hungary; Italy; Malaysia; Mexico; Netherlands; Norway; Poland; Portugal; Singapore; South Africa; Spain; Sweden; Switzerland; Taiwan; United Kingdom

References

ACTIVE Investigators; Connolly SJ, Pogue J, Hart RG, Hohnloser SH, Pfeffer M, Chrolavicius S, Yusuf S. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med. 2009 May 14;360(20):2066-78. doi: 10.1056/NEJMoa0901301. Epub 2009 Mar 31.

Reference Type: RESULT

PMID: 19336502 (View on PubMed)

Pare G, Mehta SR, Yusuf S, Anand SS, Connolly SJ, Hirsh J, Simonsen K, Bhatt DL, Fox KA, Eikelboom JW. Effects of CYP2C19 genotype on outcomes of clopidogrel treatment. N Engl J Med. 2010 Oct 28;363(18):1704-14. doi: 10.1056/NEJMoa1008410. Epub 2010 Aug 29.

Reference Type: DERIVED

PMID: 20979470 (View on PubMed)

Other Identifiers

EFC4912 A

Identifier Type: -

Identifier Source: org_study_id