Primary objective: * To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interests in patients with peripheral arterial disease (PAD) Secondary objectives: * To compare the risk of bleeding adverse events, serious adverse events and overall safety of clopidogrel with ticlopidine * To compare the risk of vascular events of clopidogrel with ticlopidine * To document the long-term safety of clopidogrel for a total of 52 weeks * To document the vascular events of clopidogrel for a total of 52 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
431
oral administration (tablets)
oral administration (tablets)
Sanofi-Aventis Administrative Office
Tokyo, Japan
Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...)
Time frame: Week 12 (on treatment)
Bleeding adverse events, Serious adverse events, Overall safety
Time frame: Week 12, 52 (on treatment)
Vascular events
Time frame: Week 12, 52 (on study)
Safety events of interest (see above)
Time frame: Week 52 (on treatment)
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