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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00249795
Registration number
NCT00249795
Ethics application status
Date submitted
4/11/2005
Date registered
7/11/2005
Date last updated
15/10/2010
Titles & IDs
Public title
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)
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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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Clopidogrel (SR25990)
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Secondary ID [2]
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EFC4912 I
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Universal Trial Number (UTN)
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Trial acronym
ACTIVE I
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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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Cardiovascular Disease
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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 - Irbesartan
Treatment: Drugs - placebo
Experimental: Irbesartan - 150 mg for 2 weeks, then up-titrated to 300 mg up to final follow-up visit
Placebo comparator: Placebo - Matching placebo up to final follow-up visit
Treatment: Drugs: Irbesartan
oral administration (tablets) once daily
Treatment: Drugs: placebo
oral administration (tablets) once daily
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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 Myocardial Infarction, Stroke or Vascular Death as Per Adjudication
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Assessment method [1]
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The first co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal) or vascular death - after validation by the Event Adjudication Committee (EAC).
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Timepoint [1]
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Median follow-up of 4.5 years
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Primary outcome [2]
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First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication
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Assessment method [2]
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The second co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal), vascular death or hospitalization for heart failure - after validation by the EAC.
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Timepoint [2]
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Median follow-up of 4.5 years
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Secondary outcome [1]
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First Occurrence of Stroke
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Assessment method [1]
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The considered event is the first occurrence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) over the duration of follow-up, after validation by the EAC.
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Timepoint [1]
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Median follow-up of 4.5 years
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Secondary outcome [2]
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Death From Any Cause
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Assessment method [2]
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The considered event is the death over the duration of the follow-up whatever the cause, cardiovascular or non-cardiovascular.
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Timepoint [2]
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Median follow-up of 4.5 years
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Secondary outcome [3]
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First Occurrence of Any Heart Failure (HF) Episode
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Assessment method [3]
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The considered event is the first occurence of any HF episode defined as evidence of signs and symptoms of HF with or without hospitalization over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).
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Timepoint [3]
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Median follow-up of 4.5 years
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Secondary outcome [4]
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First Hospitalisation for Heart Failure (HF)
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Assessment method [4]
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The considered event is the first overnight hospital stay for HF over the duration of the follow-up, after validation by the EAC.
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Timepoint [4]
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Median follow-up of 4.5 years
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Secondary outcome [5]
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First Hospitalisation for Other Cardiovascular (CV) Cause
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Assessment method [5]
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The considered event is the overnight hospital stay for any CV cause other than Heart Failure over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).
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Timepoint [5]
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Median follow-up of 4.5 years
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Eligibility
Key inclusion criteria
Should fulfill the eligibility criteria for ACTIVE A or ACTIVE W trial and:
* have a systolic blood pressure of at least 110 mmHg
* not already receiving an angiotensin receptor blocking agent, unless they are willing and able to be changed to another antihypertensive agent
* no previous intolerance to angiotensin receptor blocking agents
* no proven indication for angiotensin receptor blocking agents, unless an Angiotensin Converting Enzyme (ACE) inhibitor can be substituted
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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 study 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 acetylsalicyclic acid (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
* requirement for chronic (> 3 months) non-cyclooxygenase-2 (non-COX-2) inhibitor nonsteroidal anti-inflammatory drug (NSAID) therapy unless willing enrolled in ACTIVE A
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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 assessing the outcomes
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
1/08/2009
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Sample size
Target
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Accrual to date
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Final
9016
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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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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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Greece
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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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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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Mexico
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Netherlands
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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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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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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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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.
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Trial website
https://clinicaltrials.gov/study/NCT00249795
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Trial related presentations / publications
ACTIVE I Investigators; Yusuf S, Healey JS, Pogue J, Chrolavicius S, Flather M, Hart RG, Hohnloser SH, Joyner CD, Pfeffer MA, Connolly SJ. Irbesartan in patients with atrial fibrillation. N Engl J Med. 2011 Mar 10;364(10):928-38. doi: 10.1056/NEJMoa1008816.
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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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Fax
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00249795
Download to PDF