CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,484 enrolled
Drug / intervention
Novel strategy Aspirin +1 moredrug
Likely dose
Novel strategy Aspirin 100 mgfrom 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.

Search/NCT02520921
NCT02520921Phase 4Completed

Aspirin With a Novel Twice-a-day Administration in Diabetic Patients With Acute Coronary Syndrome to Minimize Recurrence of Acute Ischemic Events or New Urgent Revascularization

Assistance Publique - Hôpitaux de Paris·interventional·Posted Aug 13, 2015·Updated Nov 20, 2025

In Brief

A Phase 4 clinical trial evaluating Novel strategy Aspirin and Conventional strategy Aspirin for Diabetes Mellitus and 3 related conditions. Completed, enrolled 2,484 participants across 1 site.

Detailed Summary

To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg in the evening) versus Aspirin Protect® 100 mg once per day on a composite end-point of ischemic events in diabetic patients, or in patients with a known risk factor for non-optimal aspirin response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with acute coronary syndrome. It is expected that aspirin taken twice a day will reduce the occurrence of new ischemic event after acute coronary syndrome in diabetic patients or in patients with a known risk factor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
CollaboratorsBayer

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 13, 2015
Enrollment StartJun 13, 2016
Primary CompletionJul 18, 2024
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 10.9 years ago

Interventions

Novel strategy Aspirindrug

Aspirin twice a day : enteric coated enteric coated aspirin given twice a day, 100 mg in the morning and 100 mg in the evening (i.e. 200mg/day)

Conventional strategy Aspirindrug

Aspirin once day: enteric coated aspirin 100 mg in the morning (i.e. 100mg/day)