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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00249873
Registration number
NCT00249873
Ethics application status
Date submitted
4/11/2005
Date registered
7/11/2005
Date last updated
15/06/2015
Titles & IDs
Public title
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A)
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Scientific 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
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Secondary ID [1]
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EFC4912 A
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
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Vascular Risk
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - clopidogrel (SR25990C)
Treatment: Drugs - placebo
Experimental: Clopidogrel + ASA - Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
Placebo Comparator: Placebo + ASA - Matching placebo of clopidogrel 75 mg od plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
Treatment: Drugs: clopidogrel (SR25990C)
oral administration (tablets)
Treatment: Drugs: placebo
oral administration (tablets)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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expected median follow-up of approximately 3 years
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Secondary outcome [1]
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Occurrence of Stroke
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Assessment method [1]
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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.
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Timepoint [1]
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expected median follow-up of approximately 3 years
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Secondary outcome [2]
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Death From Any Cause (Cardiovascular and Noncardiovascular)
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Assessment method [2]
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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.
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Timepoint [2]
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expected median follow-up of approximately 3 years
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Secondary outcome [3]
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Adjudicated Major Bleedings
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Assessment method [3]
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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).
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Timepoint [3]
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expected median follow-up of approximately 3 years
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Eligibility
Key inclusion criteria
To be eligible for ACTIVE A patients must have in same time the three following conditions
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- 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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;
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2009
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Sample size
Target
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Accrual to date
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Final
7554
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sanofi-Aventis Administrative Office - Macquarie Park
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Recruitment postcode(s) [1]
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- Macquarie Park
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Recruitment outside Australia
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United States of America
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New Jersey
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Argentina
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Buenos Aires
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Austria
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Wien
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Diegem
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Sao Paulo
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Laval
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Chile
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Santiago
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Praha
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Horsholm
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Helsinki
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Causeway Bay
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Hungary
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Budapest
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Italy
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Milano
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Malaysia
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Kuala Lumpur
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Mexico
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Gouda
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Lysaker
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Warszawa
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Porto Salvo
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Singapore
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South Africa
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Barcelona
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Bromma
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Geneva
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Taipei
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United Kingdom
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Guildford Surrey
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Bristol-Myers Squibb
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00249873
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Philippe YUSUF, Prof.
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Address
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Hamilton Health Sciences Corporation
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00249873
Download to PDF