Overview

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.