ASCEND: A Study of Cardiovascular Events iN Diabetes
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Purpose
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 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 |
|---|---|---|
|
Diabetes Mellitus |
Drug: aspirin Drug: Omega-3-acid Ethyl Esters |
Phase 4 |
| Study Type: | Interventional |
| 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 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 ]
| Estimated Enrollment: | 15000 |
| Study Start Date: | March 2005 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United Kingdom | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr Louise Bowman, University of Oxford |
| ClinicalTrials.gov Identifier: | NCT00135226 History of Changes |
| Other Study ID Numbers: | CTSUASCEND1, EUDRACT: 2004-000991-15 |
| Study First Received: | August 24, 2005 |
| Last Updated: | August 10, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by University of Oxford:
|
Diabetes Mellitus Cardiovascular Disease Aspirin Omega-3 fatty acids |
Primary prevention Randomized Controlled Trial Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents |
Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on October 16, 2012
