ASCEND: A Study of Cardiovascular Events iN Diabetes
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|ClinicalTrials.gov Identifier: NCT00135226|
Recruitment Status : Unknown
Verified December 2015 by University of Oxford.
Recruitment status was: Active, not recruiting
First Posted : August 25, 2005
Last Update Posted : December 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Drug: aspirin Drug: Omega-3-acid Ethyl Esters Drug: Placebo Aspirin Drug: Placebo omega-3-Ethyl Esters||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15480 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||March 2005|
|Estimated Primary Completion Date :||September 2017|
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 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 ]
- Serious vascular event in various prognostic subgroups [ Time Frame: median 7.5 years follow-up ]
- Cerebral haemorrhage [ Time Frame: median 7.5 years follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135226
|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|