Clinical Trial Details
| Trial ID: | L5051 |
| Source ID: | NCT02520921 |
| Associated Drug: | Novel Strategy Aspirin |
| Title: | Aspirin Twice a Day in Patients with Diabetes and Acute Coronary Syndrome |
| Acronym: | ANDAMAN |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus|Acute Coronary Syndrome|Coronary Artery Disease|Obesity |
| Interventions: | DRUG: Novel strategy Aspirin|DRUG: Conventional strategy Aspirin |
| Outcome Measures: | Primary: first main vascular event occurring within the 18 months after randomization among the following: Death (any), Myocardial infarction, Stroke, Urgent coronary revascularization and/or stent thrombosis, Acute arterial thrombotic event, at18 months | Secondary: Major bleeding (type 3 to 5 following BARC classification, at18 months|Net clinical benefit: Death (any), Myocardial infarction, Stroke, Urgent coronary revascularization and/or stent thrombosis, Acute arterial thrombotic event, Major bleeding, at18 months|Cardiac endpoint: Cardiovascular death / Myocardial infarction, at18 months|Death, myocardial infarction, stroke, urgent revascularization, stent thrombosis, acute arterial thrombotic event and major bleeding analyzed specifically and separately, at18 months |
| Sponsor/Collaborators: | Sponsor: Assistance Publique - Hôpitaux de Paris | Collaborators: Bayer |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 2488 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2016-06-13 |
| Completion Date: | 2024-07-18 |
| Results First Posted: | |
| Last Update Posted: | 2024-12-30 |
| Locations: | Department of Cardiology - Lariboisiere Hospital, Paris, 75010, France |
| URL: | https://clinicaltrials.gov/show/NCT02520921 |
