Clinical Trial Details
| Trial ID: | L6445 |
| Source ID: | NCT03329261 |
| Associated Drug: | Clopidogrel |
| Title: | Incidence of Major Cardiovascular Events in Diabetic Patients With ACS Undergoing Coronary Angioplasty and Treated With Clopidogrel 150 mg Versus 75 mg |
| Acronym: | IDASCOP 1 |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2|NSTEMI - Non-ST Segment Elevation MI|Coronary Angioplasty |
| Interventions: | DRUG: Clopidogrel |
| Outcome Measures: | Primary: Major Cardiovascular Events (MACE), Incidence of major cardiovascular events including cardiac death, MI, cerebrovascular accident (CVA), revascularization (PTCA, GABG), stent thrombosis., 1 year after coronary intervention | Secondary: Bleeding Events, All bleeding events (digestive, cerebral, other locations), At 1, 3, 6, 9 and 12 months from patient enrollment|Heart Failure Readmission, Incidence of heart failure hospital readmissions, At 1, 3, 6, 9 and 12 months from patient enrollment|Global Death, Incidence of death of all causes (death of cardiovascular origin and death of non-cardiovascular origin), At 1, 3, 6, 9 and 12 months from patient enrollment|Incidence of Adverse Events, Incidence of Adverse Events (AE) including Serious Adverse Events (SAE), At 1, 3, 6, 9 and 12 months from patient enrollment |
| Sponsor/Collaborators: | Sponsor: Laboratoires Teriak |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 167 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2017-12-07 |
| Completion Date: | 2019-12-20 |
| Results First Posted: | |
| Last Update Posted: | 2019-12-23 |
| Locations: | HMPIT, Ben Arous, Tunisia |
| URL: | https://clinicaltrials.gov/show/NCT03329261 |
