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ISRCTN
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ISRCTN60635500
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ClinicalTrials.gov identifier
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Public title
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A Study of Cardiovascular Events iN Diabetes
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Scientific title
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A randomised 2 x 2 factorial study of aspirin versus placebo, and of omega-3 fatty acid supplementation versus placebo, for primary prevention of cardiovascular events in people with diabetes
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Acronym
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ASCEND
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Serial number at source
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CTSU ASCEND 1
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Study hypothesis
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To determine whether 100 mg daily aspirin versus placebo and/or supplementation with 1 g daily omega-3 fatty acids or placebo prevents 'serious vascular events' (i.e. non-fatal heart attack, non-fatal stroke or death from vascular causes) in patients with diabetes who are not known to have occlusive arterial disease and to assess the effects on serious bleeding or other adverse events.
Please note that as of 11/02/2009 this record was updated to include amended trial dates. The initial trial dates at the time of registration were:
Initial anticipated start date: 01/03/2005
Initial anticipated end date: 01/03/2011
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Lay summary
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Ethics approval
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Added 11/02/2009: North West Multi-centre Research Ethics Committee gave approval on the 29th December 2003 (ref: 03/8/087). Amendments approved 28th June 2004 (ref: CTSUASCEND1-1 – version 7), 1st March 2007 (ref: CTSUASCEND2 Version 8.0_010207), 23rd May 2007 (ref: CTSUASCEND3 Version 8.0_010207) and 8th July 2008 (ref: CTSUASCEND4, version 8.0_010207, 2008-06-10).
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Diabetes (type 1 & 2)
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Participants - inclusion criteria
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1. Male or female with diabetes (Type 1 or 2)
2. Aged greater than or equal to 40 years
3. No previous history of vascular disease
4. No clear contra-indication to aspirin
5. No other predominant life-threatening medical problem
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Participants - exclusion criteria
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The following point has been amended as of 11/02/2009:
2. Currently prescribed warfarin
Initial information at time of registration:
1. Definite history of myocardial infarction, stroke or arterial revascularisation procedure
2. Currently prescribed aspirin, warfarin or any other blood thinning medication
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Anticipated start date
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14/03/2005
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Anticipated end date
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31/12/2013
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Status of trial
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Ongoing |
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Patient information material
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Patient information can be found at: http://www.ctsu.ox.ac.uk/ascend/ASCEND_patientinfo.pdf
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Target number of participants
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10,000
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Interventions
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100 mg daily aspirin versus placebo and/or supplementation with 1 g daily omega-3 fatty acids or placebo.
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Primary outcome measure(s)
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The combination of non-fatal myocardial infarction, non-fatal stroke or vascular death, excluding confirmed cerebral haemorrhage
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Secondary outcome measure(s)
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1. Serious vascular event in various prognostic subgroups
2. Cerebral haemorrhage
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Sources of funding
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1. British Heart Foundation (BHF) (UK) (ref: Special Project No. SP/03/002; Grant No. PG/05/013/18296)
Added 11/02/2009:
2. BHF have agreed to fund this trial for a further 5 years (Project No. SP/08/010/25939)
3. Bayer Schering Pharma AG (UK) - providing the 100 mg aspirin tablet and equivalent placebo plus the cost of packaging and distributing the study treatment
4. Solvay Pharmaceuticals GmbH (Germany) - providing the 1 g omega-3 capsule and equivalent placebo plus the cost of packaging and distributing the study treatment
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Trial website
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http://www.ctsu.ox.ac.uk/ascend/
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Publications
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Contact name
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Prof
Jane
Armitage
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Address
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ASCEND Office
CTSU (Clinical Trial Service Unit)
Richard Doll Building
University of Oxford
Old Road Campus
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7LF
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Country
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United Kingdom
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Tel
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+44 (0)1865 743810
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Fax
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+44 (0)1865 743981
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Email
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jane.armitage@ctsu.ox.ac.uk
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Sponsor
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University of Oxford (UK)
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Address
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University Offices
Wellington Square
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City/town
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Oxford
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Zip/Postcode
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OX1 2JD
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Country
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United Kingdom
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Tel
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+44 (0)1865 270000
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Fax
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+44 (0)1865 280467
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Email
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ascend@ctsu.ox.ac.uk
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Date applied
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14/07/2005
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Last edited
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11/02/2009
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Date ISRCTN assigned
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01/09/2005
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