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

August 24, 2005
January 9, 2014
March 2005
December 2016   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
The combination of non-fatal myocardial infarction, non-fatal stroke or vascular death, excluding confirmed cerebral haemorrhage.
Complete list of historical versions of study NCT00135226 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Serious vascular event in various prognostic subgroups.
  • Cerebral haemorrhage.
Not Provided
Not Provided
 
ASCEND: A Study of Cardiovascular Events iN Diabetes
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 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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Diabetes Mellitus
  • Drug: aspirin
  • Drug: Omega-3-acid Ethyl Esters
  • Drug: Placebo Aspirin
  • Drug: Placebo omega-3-Ethyl Esters
  • Active Comparator: Aspirin + Omega-3-Ethyl Esters
    Participants receive 100mg of aspirin once daily and 1g of omega-3-Ethyl Esters once daily.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • 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.
    Interventions:
    • Drug: Placebo Aspirin
    • Drug: Placebo omega-3-Ethyl Esters
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15480
Not Provided
December 2016   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00135226
CTSUASCEND1, EUDRACT: 2004-000991-15
Not Provided
University of Oxford
University of Oxford
  • British Heart Foundation
  • Bayer
  • Abbott Products
Principal Investigator: Jane M Armitage, BSc, MBBS, MRCP, FFPH Clinical Trial Service Unit, University of Oxford
University of Oxford
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP