a double blind randomized study of Clopidogrel 75 mg/d versus placebo on a background of ASA 75-100 mg/d, in peripheral disease (PAD) patient receiving a unilateral below knee by-pass graft" - CASPAR 2004

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-000822-58-HU
• Date of registration: 14/07/2004
• Prospective Registration: Yes
• Primary sponsor: sanofi-synthelabo groupe
• Public title: a double blind randomized study of Clopidogrel 75 mg/d versus placebo on a background of ASA 75-100 mg/d, in peripheral disease (PAD) patient receiving a unilateral below knee by-pass graft" - CASPAR 2004
• Scientific title: a double blind randomized study of Clopidogrel 75 mg/d versus placebo on a background of ASA 75-100 mg/d, in peripheral disease (PAD) patient receiving a unilateral below knee by-pass graft" - CASPAR 2004
• Date of first enrolment: 14/09/2004
• Target sample size: 1460
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000822-58
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Finland, Hungary, Italy, Spain, Sweden

Key inclusion & exclusion 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 < 80 years;
- 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 dose 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.
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

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)
- 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
- 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)




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

MedDRA version: 7.0 Level: 1 Classification code 10062585

Intervention(s)

Trade Name: Plavix
Product Name: CLOPIDOGREL
Product Code: SR25990C
Pharmaceutical Form: Coated tablet
INN or Proposed INN: CLOPIDOGREL
CAS Number: NA
Current Sponsor code: SR25990C
Concentration unit: mg milligram(s)
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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.

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 (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.

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.

Secondary ID(s)

C9253

2004-000822-58-SE