NCT00135226Active, not recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 28 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 15480 (actual)
- First submitted
- 24 Aug 2005
- Start date
- Mar 2005
- Primary completion date
- 12 Mar 2018
- Lead sponsor
- University of Oxford
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT00135226
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 15480
- From Mar 2005 to the primary completion date, 12 Mar 2018
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently prescribed aspirin, warfarin or any other blood thinning medication.
Other illness
- Definite history of myocardial infarction, stroke or arterial revascularisation procedure.
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Trial Service Unit, NDPH, University of Oxford Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
Related publications
- 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 · 2025 · PMID 40010818
- 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.Contemp Clin Trials Commun · 2023 · PMID 37745288
This page is information, not medical advice. Discuss any trial with your doctor.