CASPAR : Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174759
First received: September 9, 2005
Last updated: January 10, 2011
Last verified: January 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

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
Bristol-Myers Squibb
Investigators
Study Director: Luc Sagnard Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00174759     History of Changes
Other Study ID Numbers: C_9253, EudraCT #: 2004-000822-58
Study First Received: September 9, 2005
Last Updated: January 10, 2011
Health Authority: Scotland: Scottish Executive Health Department

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on April 15, 2014