MedDRA version: 7.0 Level: 1 Classification code 10062585
Conditions
Interventions
Trade Name: Plavix
Product Name: CLOPIDOGREL
Product Code: SR25990C
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CLOPIDOGREL
CAS Number: NA
Current Sponsor code: SR25990C
Concentration
Sponsors
Sanofi-Synthelabo Groupe
Eligibility
Sex/Gender
All
Inclusion 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; - Patient aged > 40 years and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 Objective: 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.;Primary end point(s): The primary efficacy endpoint is defined as the first occurrence, over the duration of follow-up (randomization to month 24 (728 days)/study end date), of: - Occlusion of the index bypass graft documented by any imaging procedure (e.g. angiography, Duplex scanning) or - Any revascularization procedure on the index bypass graft or para-anastomotic region, defined as 2 cm proximal or distal to the bypass graft anastomosis (graft replacement or endovascular intervention) or - Amputation above the ankle of the affected limb or - Death This primary outcome will be assessed using the ITT ( Intent-to-treat) population and per protocol population. | — |
Countries
Finland, Hungary, Italy, Spain, Sweden
Outcome results
None listed