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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,460
Sanofi-Aventis
North Ryde, Australia
Sanofi-Aventis
Vienna, Austria
Sanofi-Aventis
Brussels, Belgium
Sanofi-Aventis
1st occurrence over the duration of follow-up of : index bypass graft occlusion based on imaging procedure, or graft replacement or endovascular intervention, or amputation above the ankle of the affected limb or death
1st occurrence of any component of following cluster of events : index bypass graft occlusion,any revascularization procedure or amputation. Change in ABPI.
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Helsinki, Finland
Sanofi-Aventis
Paris, France
Sanofi-Aventis
Berlin, Germany
Sanofi-Aventis
Budapest, Hungary
Sanofi-Aventis
Milan, Italy
Sanofi-Aventis
Gouda, Netherlands
Sanofi-Aventis
Warsaw, Poland
...and 4 more locations