Status:
COMPLETED
Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being Planned
Lead Sponsor:
Sanofi
Conditions:
Stable Angina
Myocardial Infarction
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
Primary objective: * To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interest in patients with stable angina (SA) or old myocardi...
Detailed Description
The study consisted of two periods: * a double blind treatment period of 12 weeks followed by, * an open label clopidogrel treatment period in a subset of patients. All patients should receive aspir...
Eligibility Criteria
Inclusion
- Stable Angina / Old Myocardial Infarction patients who met all of the following criteria:
- Myocardial ischemic finding was proven within 2 months before randomization,
- Either ≥ 75% stenosis documented by CAG or severe stenosis confirmed by multi-slice computerized tomography (MSCT) angiography within 1 month before randomization,
- PCI was being planned.
Exclusion
- Planned coronary artery bypass graft (CABG), emergent/urgent PCI, or staged PCI,
- 3-vessel coronary artery disease with significant lesions in each vessel,
- Planned PCI associated with 6 or more stent placements,
- Not less than 50% stenosis of the left main coronary artery,
- Chronic total occlusion (CTO),
- Saphenous vein graft (SVG).
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
1003 Patients enrolled
Trial Details
Trial ID
NCT00821834
Start Date
December 1 2008
End Date
August 1 2010
Last Update
July 26 2011
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Tokyo, Japan