At a glance
ClinicalIndex Comparison RecordPhase 4Active· 15,480 enrolled
Drug / intervention
Aspirin +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Aspirin, Omega-3 Ethyl Esters, and 2 other interventions for Diabetes Mellitus. Active but no longer recruiting, targeting 15,480 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesUnited Kingdom
Timeline
Phase 4Active
2005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029203020312032203320342035203620372038
Enrollment StartMar 2005
First PostedAug 2005
Primary CompletionMar 2018
TodayJul 2026
Study CompletionJul 2037
First PostedAug 25, 2005
Enrollment StartMar 1, 2005
Primary CompletionMar 12, 2018
Study CompletionJul 31, 2037
TodayJul 2, 2026
Enrollment to primary: 13.0 yearsPosted 20.9 years ago
Interventions
Aspirindrug
Omega-3 Ethyl Estersdrug
Placebo Aspirindrug
Placebo Omega-3 Ethyl Estersdrug