Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS
- Conditions
- Angina UnstableAcute Coronary Disease
- Interventions
- Drug: acetylsalicyclic acid (ASA)
- Registration Number
- NCT00335452
- Lead Sponsor
- Sanofi
- Brief Summary
The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death (CV death), myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25086
- Diagnosed with acute coronary disease with clinical symptoms and at least electrocardiogram changes or cardiac enzymes elevated
- Use of anticoagulants within 10 days with an international normalized ratio (INR) > 1.5 or planned use during the hospitalisation period
- Administration of clopidogrel > 75 mg prior to randomization
- Contraindication to clopidogrel or aspirin
- Active bleeding or significant risk of bleeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Clopidogrel standard treatment regimen + ASA low dose acetylsalicyclic acid (ASA) - Clopidogrel standard treatment regimen + ASA high dose acetylsalicyclic acid (ASA) - Clopidogrel standard treatment regimen + ASA low dose Clopidogrel - Clopidogrel high dose treatment regimen + ASA low dose acetylsalicyclic acid (ASA) - Clopidogrel high dose treatment regimen + ASA high dose acetylsalicyclic acid (ASA) - Clopidogrel high dose treatment regimen + ASA high dose Clopidogrel - Clopidogrel high dose treatment regimen + ASA low dose Clopidogrel - Clopidogrel standard treatment regimen + ASA high dose Clopidogrel -
- Primary Outcome Measures
Name Time Method First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison 30 days 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).First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison 30 days First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level 30 days First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup 30 days
- Secondary Outcome Measures
Name Time Method Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison 30 days Major bleeding is defined as any severe bleeding (associated with any of the following: death, leading to a drop in hemoglobin ≥ 5 g/dl, significant hypotension with the need for inotropic agents, symptomatic intracranial hemorrhage, requirement for surgery or for a transfusion ≥ 4 units of red blood cells or equivalent whole blood) and other major bleeding (significantly disabling bleeding, or intraocular bleeding leading to significant loss of vision or bleeding requiring transfusion of 2-3 units of red blood cells or equivalent whole blood) after validation by the independent EAC.
Occurrence of Major Bleeding - ASA Dose Level Comparison 30 days
Trial Locations
- Locations (3)
Sanofi-Aventis Administrative Office
🇬🇧Guildford, Surrey, United Kingdom
sanofi-aventis Australia & New Zealand administrative office
🇦🇺Macquarie Park, Australia
Sanofi-Aventis Admnistrative Office
🇪🇸Madrid, Spain