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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/NCT00243178
Registration number
NCT00243178
Ethics application status
Date submitted
20/10/2005
Date registered
21/10/2005
Date last updated
19/10/2009
Titles & IDs
Public title
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE W)
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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 W
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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: clopidogrel (SR25990C)
75 mg once daily in combination with aspirin
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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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Primary outcome:time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death
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Assessment method [1]
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Timepoint [1]
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during approximately three years of follow-up
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Secondary outcome [1]
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Secondary outcomes: major hemorrhage, total mortality and stroke.
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Assessment method [1]
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Timepoint [1]
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during approximately three years of follow-up
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Eligibility
Key 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.
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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; OR
- requirement for chronic (> 3 months) non-COX-2 inhibitor NSAID therapy.
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
Terminated
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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
1/07/2003
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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
1/09/2005
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Sample size
Target
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Accrual to date
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Final
6706
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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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Austria
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Wien
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Belgium
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Diegem
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Brazil
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Sao Paulo
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Canada
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Laval
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Chile
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Santiago
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Czech Republic
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Praha
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Denmark
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Horsholm
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Finland
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Helsinki
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France
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Paris
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Germany
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Berlin
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Athens
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Hong Kong
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Causeway Bay
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Hungary
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Budapest
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Israel
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Natanya
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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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Norway
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Lysaker
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Poland
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Warszawa
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Portugal
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Porto Salvo
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Russian Federation
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Moscow
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Singapore
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Singapore
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South Africa
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Midrand
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Spain
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Barcelona
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Sweden
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Bromma
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Switzerland
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Geneva
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Taiwan
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Taipei
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Turkey
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Istanbul
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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 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00243178
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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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Salim 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/NCT00243178
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