Phase 4Active, not recruiting
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
- Sponsor
- University of Oxford (Academic or other)
- Enrollment
- 15,480 enrolled
- Conditions
- Diabetes Mellitus
- Interventions
- Aspirin; Omega-3 Ethyl Esters; Placebo Aspirin; Placebo Omega-3 Ethyl Esters
- Ages
- adults, older adults
- Registry
- NCT00135226
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Number of Participants With First Occurrence of Any Serious Vascular Event (SVE)
- Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only)
History
Study completion expected
Last registry update
Results first posted
Primary completion
Registered
Started
Papers citing this trial
- Effects of aspirin and omega-3 fatty acids on age-related macular degeneration in ASCEND-Eye: a randomised placebo-controlled trial in a population with diabetes
BMJ open
- ASCEND-Eye: Rationale, design and baseline characteristics for a sub-study of the ASCEND randomised trial, exploring the effects of aspirin and omega-3 fatty acids on diabetic retinopathy and age-related macular degeneration
Contemporary clinical trials communications
- ASCEND: A Study of Cardiovascular Events iN Diabetes: Characteristics of a randomized trial of aspirin and of omega-3 fatty acid supplementation in 15,480 people with diabetes
American heart journal