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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00249873
Other study ID # EFC4912 A
Secondary ID
Status Completed
Phase Phase 3
First received November 4, 2005
Last updated May 20, 2015
Start date June 2003
Est. completion date March 2009

Study information

Verified date May 2015
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 7554
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
clopidogrel (SR25990C)
oral administration (tablets)
placebo
oral administration (tablets)

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Sanofi Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  Czech Republic,  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 & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary First Occurence of Any Component of the Composite of Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism, Myocardial Infarction or Vascular Death as Per Adjudication The primary event is the first occurence of any adjudicated component of the following cluster over the duration of follow-up :
stroke (nonfatal or fatal)
myocardial infarction (nonfatal or fatal)
non-CNS systemic embolism
vascular death
The primary efficacy analysis is performed on the time from randomization to this primary event. Numbers of patients with the composite event over the duration of the follow-up are presented by arm group.
expected median follow-up of approximately 3 years No
Secondary Occurrence of Stroke The event is the occurence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) after validation of the Event Adjudication Committee . The analysis is performed on the time from randomization to the occurrence of this event. Numbers of patients with the event over the duration of the follow-up are presented by arm group. expected median follow-up of approximately 3 years No
Secondary Death From Any Cause (Cardiovascular and Noncardiovascular) The considered event is death from any cause. The analysis is performed on the time from randomization to this event. Numbers of patients with the event over the duration of the follow-up are presented by arm group. expected median follow-up of approximately 3 years No
Secondary Adjudicated Major Bleedings The number of participants with at least one major bleeding, validated by the Event Adjudication Committee are counted over the duration of the follow-up (including after permanent discontinuation of the study drug). expected median follow-up of approximately 3 years Yes
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