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.
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 aspirin (81-100 mg once daily) as a background therapy during investigational product administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,003
Form: tablets Route: oral
Form: tablets Route: oral
Form: tablets Route: oral
Sanofi-Aventis Administrative Office
Tokyo, Japan
Time from randomization to first safety events of interest
Safety events of interest were: * Clinically significant bleeding, * Leukopenia, neutropenia or thrombocytopenia occurring as adverse drug reaction, * Elevated liver function values occurring as adverse drug reaction, * Permanent investigational product discontinuation due to skin disorders, gastrointestinal disorders, bleeding, hepatic disorders, or significant decreases in such tests as leukocytes, neutrophils or platelets occurring as adverse drug reaction.
Time frame: 12 Weeks (duble blind treatment period)
Time from randomization to first Major Adverse Cardiac Events (MACE)
MACE included: * All- cause mortality, * Acute myocardial infarction, * Revascularization (excluding revascularization related to the planned PCI), * Stent thrombosis
Time frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Time from randomization to first bleeding events
Time frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Time from randomization to first Adverse Events / Adverse Drug Reactions
Time frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Time from randomization to first Major Adverse Cardiac and Cerebrovascular Events (MACCE)
MACCE included: * All- cause mortality, * Acute myocardial infarction, * Revascularization (excluding revascularization related to the planned PCI), * Stent thrombosis, * Ischemic stroke.
Time frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
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