Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Peripheral Arterial Disease (PAD)

Intervention / Treatment
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* Drug: clopidogrel (SR25990)
* Drug: ticlopidine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clopidogrel<br>75 mg clopidogrel once daily from Day 1 to Week 12 | Drug: clopidogrel (SR25990)<br>* oral administration (tablets)<br>|
| Active Comparator: Ticlopidine<br>200 mg ticlopidine once daily from Day 1 to Week 12 | Drug: ticlopidine<br>* oral administration (tablets)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...) |  | Week 12 (on treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding adverse events, Serious adverse events, Overall safety |  | Week 12, 52 (on treatment) | 
| Vascular events |  | Week 12, 52 (on study) | 
| Safety events of interest (see above) |  | Week 52 (on treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet aggregation inhibitors, Peripheral arterial disease (PAD)