CASPAR : Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arterial Occlusive Diseases
Intervention: Clopidogrel (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Luc Sagnard, Study Director, Affiliation: Sanofi-Aventis
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
Clinical Details
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.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: 1st occurrence of any component of following cluster of events : index bypass graft occlusion,any revascularization procedure or amputation. Change in ABPI.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Sanofi-Aventis, North Ryde, Australia
Sanofi-Aventis, Vienna, Austria
Sanofi-Aventis, Brussels, Belgium
Sanofi-Aventis, 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
Sanofi-Aventis, Barcelona, Spain
Sanofi-Aventis, Stockholm, Sweden
Sanofi-Aventis, Meyrin, Switzerland
Sanofi-Aventis, Guildford, United Kingdom
Additional Information
Starting date: September 2004
Last updated: January 2, 2008
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