CASPAR : Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease
- Conditions
- Arterial Occlusive Diseases
- Registration Number
- NCT00174759
- Lead Sponsor
- Sanofi
- 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 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1460
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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 1st occurrence of any component of following cluster of events : index bypass graft occlusion,any revascularization procedure or amputation. Change in ABPI.
Trial Locations
- Locations (1)
Sanofi-Aventis
🇬🇧Guildford, United Kingdom