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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00174759




Registration number
NCT00174759
Ethics application status
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
11/01/2011

Titles & IDs
Public title
CASPAR : Clopidogrel and Acetyl Salicylic Acid in Bypass Surgery for Peripheral ARterial Disease
Scientific 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.
Secondary ID [1] 0 0
EudraCT #: 2004-000822-58
Secondary ID [2] 0 0
C_9253
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arterial Occlusive Diseases 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Clopidogrel

Treatment: Drugs: Clopidogrel


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Secondary outcome [1] 0 0
1st occurrence of any component of following cluster of events : index bypass graft occlusion,any revascularization procedure or amputation. Change in ABPI.
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis - North Ryde
Recruitment postcode(s) [1] 0 0
- North Ryde
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Finland
State/province [3] 0 0
Helsinki
Country [4] 0 0
France
State/province [4] 0 0
Paris
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
Hungary
State/province [6] 0 0
Budapest
Country [7] 0 0
Italy
State/province [7] 0 0
Milan
Country [8] 0 0
Netherlands
State/province [8] 0 0
Gouda
Country [9] 0 0
Poland
State/province [9] 0 0
Warsaw
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
Sweden
State/province [11] 0 0
Stockholm
Country [12] 0 0
Switzerland
State/province [12] 0 0
Meyrin
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Guildford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/show/NCT00174759
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Luc Sagnard
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications