Arterial Occlusive Diseases Clinical Trial
Official title:
A Double-blind, Randomized Study of Clopidogrel 75 mg/d vs Placebo, on a Background of ASA 75-100 mg/d,in Peripheral Arterial Disease (PAD) Patients Receiving a Unilateral Below Knee Bypass Graft.
Primary objective:
To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100
mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in
patients receiving a below knee bypass graft for the treatment of PAD.
Secondary objectives:
Comparison, between the two treatment groups, of :
- Primary patency,
- Assisted primary patency,
- Cardiovascular death / myocardial infarction / stroke / any amputation above the ankle.
- Ankle Brachial Pressure Index (ABPI) changes from baseline
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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