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Trial record 57 of 78 for:    sanofi-aventis and sweden

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00174759
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 11, 2011
Bristol-Myers Squibb
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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

Condition or disease Intervention/treatment Phase
Arterial Occlusive Diseases Drug: Clopidogrel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : September 2004

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00174759

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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00174759     History of Changes
Other Study ID Numbers: C_9253
EudraCT #: 2004-000822-58
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs