A double blind randomized study of Clopidogrel 75 mg/d versus placebo on a background of ASA 75-100 mg/d, in peripheral arterial disease (PAD) patients receiving a unilateral below knee by-pass graft - CASPAR 2004
- Conditions
- Peripheral arterial diseaseMedDRA version: 7.0Level: 1Classification code 10062585
- Registration Number
- EUCTR2004-000822-58-FI
- Lead Sponsor
- sanofi-synthelabo groupe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1460
A patient is eligible for inclusion in the study 2-4 days after surgery if all the following criteria are fulfilled:
- Informed consent obtained;
- Patient aged > 40 years and < 80 years;
- Chronic background treatment with daily ASA or Triflusal, whatever the dose, started at least 4 weeks before surgery. A window of a few days without ASA or Triflusal before surgery is acceptable, according to local practice.
-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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients having any of the following at randomization will not be included in the study:
?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)
-Patients undergoing, along with the below knee bypass any other surgical intervention (or who has undergone one within the last four weeks before surgery), except endovascular procedures of the opposite leg at the femoral level or below (cf note below).
-Any aneurysm in or near the operated segment
?Medical history related to bleeding risk
-Current active bleeding at surgical site
-Withdrawal of an epidural catheter less than 12 hours before randomization
-Increased risk of bleeding, such as severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy, history of severe systemic bleeding (e.g. gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke or intracranial hemorrhage) or other history of bleeding diathesis or coagulopathy.
?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
-High probability of death of non-cardiovascular cause, within the next 12 months.
-History of clinically significant or persistent thrombocytopenia or current platelet count less than 120 G/L
-History of clinically significant or persistent neutropenia or current neutrophil count less than 1.8 G/L
-Pregnant women , or women of childbearing potential who are not following an effective method of contraception.
?Recent or planned medical therapy
-Thrombolytic therapy within 24 hours prior to randomization, or use of GPIIb/IIIa receptor antagonist within 4 days prior to randomization
-Hypersensitivity to the drug substance or any component of the product
-Associated condition requiring chronic use of oral anticoagulants (e.g. warfarin, ximelagatran) or antiplatelet agents (including dipyridamole, cilostazol, GPIIb/IIIa antagonists, ticlopidine, clopidogrel or ASA>100mg/d)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method