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” (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.

Condition	Intervention	Phase
Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus	Drug: aspirin  Drug: Omega-3-acid Ethyl Esters	Phase IV

Further Study Details: 

Primary Outcomes: The combination of non-fatal myocardial infarction, non-fatal stroke or vascular death, excluding confirmed cerebral haemorrhage.
Secondary Outcomes: Serious vascular event in various prognostic subgroups.; Cerebral haemorrhage.
Expected Total Enrollment:  10000

The role of antiplatelet therapy (chiefly aspirin) for the secondary prevention of heart attacks and strokes is firmly established for many high-risk people with diagnosed arterial disease, and the proportional reductions in these cardiovascular events appear to be about one quarter, whether or not such patients have diabetes. But, most younger and middle-aged people with diabetes do not have manifest arterial disease - although they are still at significant cardiovascular risk - and yet few trials have tested aspirin in such individuals. As a result, there is substantial uncertainty about the role of aspirin for the prevention of heart attacks and strokes among apparently healthy people with diabetes, and only a small minority receives it.

There is consistent evidence from observational studies of lower rates of cardiovascular disease (particularly cardiac and sudden death) in people with higher intakes, or higher blood levels, of fish oils (omega-3 fatty acids). Trials in people who have survived a heart attack have shown modest, but potentially worthwhile, reductions in coronary events. There have been, however, no large-scale trials of the use of fish oils for the prevention of vascular events in people without diagnosed arterial disease.

If ASCEND can reliably demonstrate that aspirin and/or fish oils safely reduce the risk of cardiovascular events and deaths in people with diabetes who do not have pre-existing arterial disease, then this would be relevant to some tens of millions of people world-wide (who are currently not receiving such therapy) and might save tens of thousands of lives each year.

Ages Eligible for Study:  40 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Male or female with Type 1 or 2 Diabetes Mellitus.
• Aged ≥40 years.
• 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 aspirin, warfarin or any other blood thinning medication.

Please refer to this study by ClinicalTrials.gov identifier  NCT00135226

Jill Barton      44 1865 743814    jill.barton@ctsu.ox.ac.uk
Louise J Bowman, BA, MBBS, MRCP      441865 743875    louise.bowman@ctsu.ox.ac.uk

United Kingdom
      Clinical Trial Service Unit, University of Oxford, Oxford,  OX3 7LF,  United Kingdom; Recruiting

Study chairs or principal investigators

Jane M Armitage, BSc, MBBS, MRCP, FFPH,  Principal Investigator,  Clinical Trial Service Unit, University of Oxford   

Study ID Numbers:  CTSUASCEND1; EUDRACT: 2004-000991-15
Last Updated:  August 24, 2005
Record first received:  August 24, 2005
ClinicalTrials.gov Identifier:  NCT00135226
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-08-30