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

  1. Study completion expected

  2. Last registry update

  3. Results first posted

  4. Primary completion

  5. Registered

  6. Started

Papers citing this trial