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CASPAR : Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease
This study has been completed.
First Received: September 9, 2005   Last Updated: September 17, 2009   History of Changes
Sponsor: Sanofi-Aventis
Collaborator: Bristol-Myers Squibb
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00174759
  Purpose

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

Condition Intervention Phase
Arterial Occlusive Diseases
Drug: Clopidogrel
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • 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:
  • 1st occurrence of any component of following cluster of events : index bypass graft occlusion,any revascularization procedure or amputation. Change in ABPI.

Estimated Enrollment: 1460
Study Start Date: September 2004
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174759

Locations
Australia
Sanofi-aventis
North Ryde, Australia
Austria
Sanofi-aventis
Vienna, Austria
Belgium
Sanofi-aventis
Brussels, Belgium
Finland
Sanofi-aventis
Helsinki, Finland
France
Sanofi-aventis
Paris, France
Germany
Sanofi-aventis
Berlin, Germany
Hungary
Sanofi-aventis
Budapest, Hungary
Italy
Sanofi-aventis
Milan, Italy
Netherlands
Sanofi-aventis
Gouda, Netherlands
Poland
Sanofi-aventis
Warsaw, Poland
Spain
Sanofi-aventis
Barcelona, Spain
Sweden
Sanofi-aventis
Stockholm, Sweden
Switzerland
Sanofi-aventis
Meyrin, Switzerland
United Kingdom
Sanofi-aventis
Guildford, United Kingdom
Sponsors and Collaborators
Sanofi-Aventis
Bristol-Myers Squibb
Investigators
Study Director: Luc Sagnard Sanofi-Aventis
  More Information

Additional Information:
No publications provided

Study ID Numbers: C-9253, EudraCT #: 2004-000822-58
Study First Received: September 9, 2005
Last Updated: September 17, 2009
ClinicalTrials.gov Identifier: NCT00174759     History of Changes
Health Authority: Scotland: Scottish Executive Health Department

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Vascular Diseases
Therapeutic Uses
Clopidogrel
Hematologic Agents
Vascular Diseases
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010