ASCEND: A Study of Cardiovascular Events iN Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
British Heart Foundation
Bayer
Abbott Products
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT00135226
First received: August 24, 2005
Last updated: January 9, 2014
Last verified: January 2014
  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 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.


Condition Intervention Phase
Diabetes Mellitus
Drug: aspirin
Drug: Omega-3-acid Ethyl Esters
Drug: Placebo Aspirin
Drug: Placebo omega-3-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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15480
Study Start Date: March 2005
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00135226

Locations
United Kingdom
Clinical Trial Service Unit, University of Oxford
Oxford, United Kingdom, OX3 7LF
Sponsors and Collaborators
University of Oxford
British Heart Foundation
Bayer
Abbott Products
Investigators
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: 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: January 9, 2014
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 April 14, 2014