ASCEND
A Study of Cardiovascular Events iN Diabetes
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Status:
Ongoing. Study began in March 2005 and is currently recruiting patients.
Purpose:
To determine whether 100mg daily aspirin versus placebo and/or supplementation with 1 gram daily omega-3 fatty acids or placebo prevents “serious vascular events” in patients with diabetes who are not known to have occlusive arterial disease.
Location(s):
United Kingdom
Year Started:
2005
Design:
Intervention, prevention, randomized, double-blind, placebo control, factorial assignment, safety/efficacy study.
Inclusion Criteria
Males or females with type 1 or type 2 diabetes mellitus. No previous history of vascular disease. No clear contra-indication to aspirin. No other predominant life-threatening medical problem.
Exclusion Criteria
Definite history of myocardial infarction, stroke or arterial revascularisation procedure. Currently prescribed warfarin or other anticoagulant therapy.
Patient Involvement:
This trial is UK-based and is run predominantly by mail. Study medication and follow-up questionnaires are sent by mail, with 24-hour telephone advice available from the coordinating centre for any queries.
Primary Outcome:
The combination of non-fatal myocardial infarction, non-fatal stroke or vascular mortality, excluding confirmed cerebral hemorrhage.
Secondary Outcome:
Serious vascular event in various prognostic subgroups; cerebral haemorrhage.
Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 7/21/2009
Reviewed on: 01/17/2009.
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