Who is sponsoring NCT00135226?

NCT00135226 is sponsored by University of Oxford.

What condition does NCT00135226 study?

NCT00135226 studies Diabetes Mellitus.

What drugs are being tested in NCT00135226?

Interventions: Aspirin, Omega-3 Ethyl Esters, Placebo Aspirin, Placebo Omega-3 Ethyl Esters.

What is the status of NCT00135226?

NCT00135226 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2025-05-16 · How we verify

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

NCT00135226 Phase 4 ACTIVE_NOT_RECRUITING Results posted

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.

Details

Lead sponsor	University of Oxford
Phase	Phase 4
Status	ACTIVE_NOT_RECRUITING
Enrolment	15480
Start date	2005-03
Completion	2037-07-31

Conditions

Diabetes Mellitus

Interventions

Aspirin
Omega-3 Ethyl Esters
Placebo Aspirin
Placebo Omega-3 Ethyl Esters

Primary outcomes

Number of Participants With First Occurrence of Any Serious Vascular Event (SVE) — Randomized treatment phase during a mean of 7.4 years
The primary efficacy assessments involve intention-to-treat comparisons among all randomized participants of allocation to aspirin versus placebo and, separately, of omega-3 fatty acids versus placebo on the first occurrence of any "Serious Vascular Event" (SVE), defined as: * non-fatal myocardial infarction; or * non-fatal stroke (excluding confirmed intracranial hemorrhage) or TIA; or * vascular death excluding confirmed intracranial hemorrhage (defined as International Classification of Diseases 10th revision \[ICD-10\] I00-52 or I63-99, i.e. excluding subarachnoid hemorrhage \[I60\], intracerebral hemorrhage \[I61\], and other non-traumatic intracranial hemorrhage \[I62\]).
Number of Participants With First Occurrence of Any Major Bleed (Aspirin Comparison Only) — Randomized treatment phase during a mean of 7.4 years
The primary safety assessments involve intention-to-treat comparisons among all randomized patients of allocation to aspirin versus placebo on the first occurrence of "any major bleed", defined as: * any confirmed intracranial hemorrhage (including intracerebral, subarachnoid, subdural or any other intracranial hemorrhage); or * sight-threatening eye bleeding; or * any other serious bleeding episode.

Countries

United Kingdom