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

Arterial Occlusive Diseases Clinical Trial

Official title:

A Double-blind, Randomized Study of Clopidogrel 75 mg/d vs Placebo, on a Background of ASA 75-100 mg/d,in Peripheral Arterial Disease (PAD) Patients Receiving a Unilateral Below Knee Bypass Graft.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174759
• Other study ID #: C_9253
• Secondary ID: EudraCT #: 2004-
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: January 10, 2011
• Start date: September 2004

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Scotland: Scottish Executive Health Department
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1460
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• Clopidogrel

Locations

Country	Name	City	State
Australia	Sanofi-Aventis	North Ryde
Austria	Sanofi-Aventis	Vienna
Belgium	Sanofi-Aventis	Brussels
Finland	Sanofi-Aventis	Helsinki
France	Sanofi-Aventis	Paris
Germany	Sanofi-Aventis	Berlin
Hungary	Sanofi-Aventis	Budapest
Italy	Sanofi-Aventis	Milan
Netherlands	Sanofi-Aventis	Gouda
Poland	Sanofi-Aventis	Warsaw
Spain	Sanofi-Aventis	Barcelona
Sweden	Sanofi-Aventis	Stockholm
Switzerland	Sanofi-Aventis	Meyrin
United Kingdom	Sanofi-Aventis	Guildford

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Bristol-Myers Squibb

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Finland,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1st occurrence over the duration of follow-up of : index bypass graft occlusion based on imaging procedure, or graft replacement or endovascular intervention, or amputation above the ankle of the affected limb or death
Secondary	1st occurrence of any component of following cluster of events : index bypass graft occlusion,any revascularization procedure or amputation. Change in ABPI.