Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00335452 | Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS | PHASE3 | COMPLETED | 25,086 | — | — | Jun 1, 2006 | Sep 1, 2009 | Nov 18, 2010 | 38 | United States, Argentina +36 |
The primary endpoint is the first occurrence of any of the following events: * Cardiovascular death (any death with a clear cardiovascular or unknown cause), * Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal) * Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal) reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC).
| Arm | Type | Description |
|---|---|---|
| Clopidogrel high dose treatment regimen + ASA high dose | EXPERIMENTAL | - |
| Clopidogrel high dose treatment regimen + ASA low dose | EXPERIMENTAL | - |
| Clopidogrel standard treatment regimen + ASA high dose | ACTIVE_COMPARATOR | - |
| Clopidogrel standard treatment regimen + ASA low dose | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Clopidogrel | DRUG | oral administration |
| acetylsalicyclic acid (ASA) | DRUG | oral administration |
Inclusion Criteria: * Diagnosed with acute coronary disease with clinical symptoms and at least electrocardiogram changes or cardiac enzymes elevated Exclusion Criteria: * Use of anticoagulants within 10 days with an international normalized ratio (INR) \> 1.5 or planned use during the hospitalis...