Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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.