Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

A Randomized, Double Blind, Parallel Group Study to Investigate the Safety of 12 Weeks of Clopidogrel 75 mg/Day Versus Ticlopidine 200 mg/Day in Patients With Peripheral Arterial Disease - With Extended Treatment of Clopidogrel 75 mg/Day for 40 Weeks

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

Inclusion Criteria:

Documented symptomatic peripheral arterial disease (one or both of the following two primary criteria must be satisfied):

• Current intermittent claudication with Ankle Brachial Index (ABI) < 0.90
• A history of intermittent claudication together with previous related intervention in a leg

Exclusion Criteria:

• Patients who had acute atherothrombotic events or any invasive therapies within 30 days before the randomization, or patients who planned any invasive therapies within 12 weeks after the randomization
• Bleeding diathesis, coagulopathy and present bleeding disease
• Previous intracranial bleeding or hemorrhagic stroke
• Uncontrolled hypertension

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.