Status:
COMPLETED
CASPAR : Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Arterial Occlusive Diseases
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief 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 pati...
Eligibility Criteria
Inclusion
- Inclusion Criteria: A patient is eligible for inclusion in the study 2-4 days after surgery if all the following criteria are fulfilled:
- Informed consent obtained;
- Chronic background treatment with daily ASA, whatever the dose, started at least 4 weeks before surgery. A window of a few days without ASA before surgery is acceptable, according to local practice. Post-randomization use of ASA must be between 75 and 100 mg/day.
- Unilateral below knee bypass graft (i.e. the distal anastomosis is below the level of the knee joint) for atherosclerotic PAD within the previous 4 days;
- Demonstration of initial patency of the index graft by an objective measurement (e.g. intra-operative Doppler scanning, flow measurement, angiography, Duplex scanning) during bypass surgery, or between surgery and the time of randomization;
- No clinical evidence of graft occlusion at time of randomization.
- Exclusion criteria :
- PAD medical/surgical history
- Onset of PAD symptoms before the age of 40 years
- Non-atherosclerotic vascular disease (e.g. Buerger's disease, popliteal entrapment syndrome)
- Patient receiving aorto-bifemoral, iliac-femoral or crossover (femoral-femoral) grafts, or undergoing peripheral transcutaneous angioplasty (PTA), with or without stenting, during the same surgery.
- Medical history related to bleeding risk
- Current active bleeding at surgical site
- Withdrawal of an epidural catheter less than 12 hours before randomization
- Current active bleeding or increased risk of bleeding, such as severe hepatic insufficiency, proliferative diabetic retinopathy, peptic ulceration, bleeding diathesis or coagulopathy
- Peptic ulceration within 12 months of randomization
- Previous or current intracranial hemorrhage or hemorrhagic stroke, or any previous stroke for which the diagnosis of hemorrhagic stroke cannot be excluded
- Any history of severe spontaneous bleeding such as gastrointestinal bleeding, gross hematuria, intraocular bleeding
- Other medical conditions
- Previous disabling stroke (severe cerebral deficit such that the patient is bedridden or demented)
- NYHA Class IV heart failure
- Uncontrolled hypertension: Systolic Blood Pressure (SBP) \> 180 mm Hg, or Diastolic Blood Pressure (DBP) \> 100 mm Hg
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
1460 Patients enrolled
Trial Details
Trial ID
NCT00174759
Start Date
September 1 2004
Last Update
January 11 2011
Active Locations (14)
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1
Sanofi-Aventis
North Ryde, Australia
2
Sanofi-Aventis
Vienna, Austria
3
Sanofi-Aventis
Brussels, Belgium
4
Sanofi-Aventis
Helsinki, Finland