Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being Planned

• Status: Completed
• Trial end date: 2010-08-01

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 myocardial infarction (OMI) to which percutaneous coronary intervention (PCI) is being planned.

Secondary objectives:

• To compare the incidence of adverse events, adverse drug reactions and bleeding events in patients treated with clopidogrel versus ticlopidine.

• To compare the incidence of major adverse cardiac events (MACE) and major adverse cardiac and cerebrovascular events (MACCE) in patients treated with clopidogrel versus ticlopidine.

• To evaluate the long-term safety (adverse drug reactions, adverse events, safety events of interest and bleeding events) of clopidogrel for a total of 52 weeks;

• To evaluate MACE and MACCE of clopidogrel for a total of 52 weeks.

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Treatments: Clopidogrel; Platelet Aggregation Inhibitors; Ticlopidine