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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Arterial Occlusive Diseases

Treatments

Drug: Clopidogrel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00174759

EudraCT #: 2004-000822-58

C_9253

Details and patient eligibility

About

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

Enrollment

1,460 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and 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;
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