ASCEND: A Study of Cardiovascular Events iN Diabetes

Active, not recruiting

Phase 4 Results N/A

Trial Description

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.

Detailed 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.

Conditions

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Omega-3 fatty acids Drug
    Other Names: Omacor (ethyl esters of omega-3 polyunsaturated fatty acids)
  • Aspirin Drug
    ARM 1: Kind: Experimental
    Label: Aspirin + Omega-3-Ethyl Esters
    Description: Participants receive 100mg of aspirin once daily and 1g of omega-3-Ethyl Esters once daily.
    ARM 2: Kind: Experimental
    Label: Aspirin + Placebo Omega-3-Ethyl Esters
    Description: Participants receive 100mg of aspirin once daily and placebo omega-3-Ethyl Esters once daily.
  • Omega-3-acid Ethyl Esters Drug
    ARM 1: Kind: Experimental
    Label: Aspirin + Omega-3-Ethyl Esters
    Description: Participants receive 100mg of aspirin once daily and 1g of omega-3-Ethyl Esters once daily.
    ARM 2: Kind: Experimental
    Label: Placebo Aspirin + Omega-3-Ethyl Esters
    Description: Participants receive placebo aspirin once daily and 1 g of omega-3-Ethyl Esters once daily.
  • Placebo Aspirin Drug
    ARM 1: Kind: Experimental
    Label: Placebo Aspirin + Omega-3-Ethyl Esters
    Description: Participants receive placebo aspirin once daily and 1 g of omega-3-Ethyl Esters once daily.
    ARM 2: Kind: Experimental
    Label: Placebo Aspirin + Placebo Omega-3-Ethyl Esters
    Description: Participants receive placebo aspirin once daily and placebo omega-3-Ethyl Esters once daily.
  • Placebo omega-3-Ethyl Esters Drug
    ARM 1: Kind: Experimental
    Label: Aspirin + Placebo Omega-3-Ethyl Esters
    Description: Participants receive 100mg of aspirin once daily and placebo omega-3-Ethyl Esters once daily.
    ARM 2: Kind: Experimental
    Label: Placebo Aspirin + Placebo Omega-3-Ethyl Esters
    Description: Participants receive placebo aspirin once daily and placebo omega-3-Ethyl Esters once daily.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Factorial Assignment

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary The combination of non-fatal myocardial infarction, non-fatal stroke or vascular mortality, excluding confirmed cerebral hemorrhage.
Secondary Serious vascular event in various prognostic subgroups; cerebral haemorrhage.
Primary The combination of non-fatal myocardial infarction, non-fatal stroke or vascular death, excluding confirmed cerebral haemorrhage median 7.5 years follow-up No
Secondary Serious vascular event in various prognostic subgroups median 7.5 years follow-up No
Secondary Cerebral haemorrhage median 7.5 years follow-up Yes
Primary The combination of non-fatal myocardial infarction, non-fatal stroke or transient ischaemic attack, or vascular death, excluding confirmed cerebral haemorrhage median 7.5 years follow-up No

Sponsors