ASCEND: A Study of Cardiovascular Events iN Diabetes
The purpose of this study is 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 transient ischaemic attack, 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.
Drug: Omega-3-acid Ethyl Esters
Drug: Placebo Aspirin
Drug: Placebo omega-3-Ethyl Esters
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Study of Cardiovascular Events iN Diabetes - A Randomized 2x2 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|
- The combination of non-fatal myocardial infarction, non-fatal stroke or transient ischaemic attack, or vascular death, excluding confirmed cerebral haemorrhage [ Time Frame: median 7.5 years follow-up ] [ Designated as safety issue: No ]
- Serious vascular event in various prognostic subgroups [ Time Frame: median 7.5 years follow-up ] [ Designated as safety issue: No ]
- Cerebral haemorrhage [ Time Frame: median 7.5 years follow-up ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2005|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Aspirin + Omega-3-Ethyl Esters
Participants receive 100mg of aspirin once daily and 1g of omega-3-Ethyl Esters once daily.
|Drug: aspirin Drug: Omega-3-acid Ethyl Esters|
Active Comparator: Aspirin + Placebo Omega-3-Ethyl Esters
Participants receive 100mg of aspirin once daily and placebo omega-3-Ethyl Esters once daily.
|Drug: aspirin Drug: Placebo omega-3-Ethyl Esters|
Active Comparator: Placebo Aspirin + Omega-3-Ethyl Esters
Participants receive placebo aspirin once daily and 1 g of omega-3-Ethyl Esters once daily.
|Drug: Omega-3-acid Ethyl Esters Drug: Placebo Aspirin|
Active Comparator: Placebo Aspirin + Placebo Omega-3-Ethyl Esters
Participants receive placebo aspirin once daily and placebo omega-3-Ethyl Esters once daily.
|Drug: Placebo Aspirin Drug: Placebo omega-3-Ethyl Esters|
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.
|Clinical Trial Service Unit, University of Oxford|
|Oxford, United Kingdom, OX3 7LF|
|Principal Investigator:||Jane M Armitage, BSc, MBBS, MRCP, FFPH||Clinical Trial Service Unit, University of Oxford|