NCT00174759

CASPAR : Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,460 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Arterial Occlusive Diseases

Interventions

Type	Name	Description
DRUG	Clopidogrel

Timeline

• Start date: 2004-09-01
• First posted: 2005-09-15
• Last updated: 2011-01-11

Locations

14 sites across 14 countries: Australia, Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom