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

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00174759
Collaborator
Bristol-Myers Squibb (Industry)
1,460
Enrollment
14
Locations
104.3
Patients Per Site

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 1, 2004

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sanofi-Aventis North Ryde Australia
2 Sanofi-Aventis Vienna Austria
3 Sanofi-Aventis Brussels Belgium
4 Sanofi-Aventis Helsinki Finland
5 Sanofi-Aventis Paris France
6 Sanofi-Aventis Berlin Germany
7 Sanofi-Aventis Budapest Hungary
8 Sanofi-Aventis Milan Italy
9 Sanofi-Aventis Gouda Netherlands
10 Sanofi-Aventis Warsaw Poland
11 Sanofi-Aventis Barcelona Spain
12 Sanofi-Aventis Stockholm Sweden
13 Sanofi-Aventis Meyrin Switzerland
14 Sanofi-Aventis Guildford United Kingdom

Sponsors and Collaborators

  • Sanofi
  • Bristol-Myers Squibb

Investigators

  • Study Director: Luc Sagnard, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00174759
Other Study ID Numbers:
  • C_9253
  • EudraCT #: 2004-000822-58
First Posted:
Sep 15, 2005
Last Update Posted:
Jan 11, 2011
Last Verified:
Jan 1, 2011
Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Clopidogrel

Study Results

No Results Posted as of Jan 11, 2011