Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatments aspirin, omega-3-acid ethyl esters, placebo aspirin, placebo omega-3-ethyl esters
Phase phase 4
Sponsor University of Oxford
Collaborator British Heart Foundation
Start date March 2005
End date December 2016
Trial size 15480 participants
Trial identifier NCT00135226, CTSUASCEND1, EUDRACT: 2004-000991-15

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Participants receive 100mg of aspirin once daily and 1g of omega-3-Ethyl Esters once daily.
aspirin
omega-3-acid ethyl esters
(Active Comparator)
Participants receive 100mg of aspirin once daily and placebo omega-3-Ethyl Esters once daily.
aspirin
placebo omega-3-ethyl esters
(Active Comparator)
Participants receive placebo aspirin once daily and 1 g of omega-3-Ethyl Esters once daily.
omega-3-acid ethyl esters
placebo aspirin
(Active Comparator)
Participants receive placebo aspirin once daily and placebo omega-3-Ethyl Esters once daily.
placebo aspirin
placebo omega-3-ethyl esters

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 40 years old.

Inclusion Criteria: - Males or females with type 1 or type 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.

Additional Information

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
Principal investigator Jane M Armitage, BSc, MBBS, MRCP, FFPH
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University of Oxford.