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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trial of Clopidogrel After Surgery for Coronary Artery Disease (CASCADE Trial)

NCT00228423

Atherosclerosis

COMPLETED PHASE2

Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA)

NCT00050817

Arteriosclerosis

COMPLETED PHASE3

Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects

NCT02502812

Cardiovascular Disease

COMPLETED PHASE1

The Clopidogrel and Aspirin After Surgery for Coronary Artery Disease

NCT00776477

Atherosclerosis

UNKNOWN PHASE3

Antiplatelet Strategy for Peripheral Arterial Interventions for Revascularization of Lower Extremities

NCT02217501

Peripheral Arterial Disease

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arterial Occlusive Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clopidogrel

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No