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.
2 other identifiers
interventional
1,460
13 countries
13
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedJanuary 11, 2011
January 1, 2011
September 9, 2005
January 10, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
1st occurrence of any component of following cluster of events : index bypass graft occlusion,any revascularization procedure or amputation. Change in ABPI.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
- Bristol-Myers Squibbcollaborator
Study Sites (14)
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
Related Publications (1)
Belch JJ, Dormandy J; CASPAR Writing Committee; Biasi GM, Cairols M, Diehm C, Eikelboom B, Golledge J, Jawien A, Lepantalo M, Norgren L, Hiatt WR, Becquemin JP, Bergqvist D, Clement D, Baumgartner I, Minar E, Stonebridge P, Vermassen F, Matyas L, Leizorovicz A. Results of the randomized, placebo-controlled clopidogrel and acetylsalicylic acid in bypass surgery for peripheral arterial disease (CASPAR) trial. J Vasc Surg. 2010 Oct;52(4):825-33, 833.e1-2. doi: 10.1016/j.jvs.2010.04.027. Epub 2010 Aug 1.
PMID: 20678878DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Luc Sagnard
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
September 1, 2004
Last Updated
January 11, 2011
Record last verified: 2011-01