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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2004-000822-58
    Sponsor's Protocol Code Number:C9253
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-10
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2004-000822-58
    A.3Full title of the trial
    Clopidogrel and Acetyl salicylic acid in bypass Surgery for Peripheral ARterial disease. A double blind randomised study of clopidogrel 75 mg/d versus placebo on a background of ASA 75-100 mg/d, in peripheral arterial disease (PAD) patients receiving a unilateral below knee by-pass graft
    A.3.2Name or abbreviated title of the trial where available
    CASPAR 2004
    A.4.1Sponsor's protocol code numberC9253
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNA
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi-Synthelabo Groupe
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name Plavix 75 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Pharma Bristol-Myers Squibb SNC
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCLOPIDOGREL
    D.3.2Product code SR25990C
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level 1
    E.1.2Classification code 10062585
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal 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 or Triflusal, whatever the dose, started at least 4 weeks before surgery.
    A window of a few days without ASA or Triflusal 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.
    E.4Principal 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)
    - Patients undergoing, along with the below knee bypass any other surgical intervention (or who has undergone one within the last four weeks before surgery), except endovascular procedures of the opposite leg at the femoral level or below (cf note below).
    - Any aneurysm in or near the operated segment

     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
    - 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)

     Other exclusion criteria
    - Simultaneous or previous participation (in the 30 days prior to study entry) in a clinical study using an experimental drug or device
    - Prior enrolment in this trial
    - Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study, or language barrier such that the subject is unable to give informed consent
    - Uncooperative attitude or potential for non-compliance with the requirements of the protocol making study participation impractical.

    Note:
    1) Only patients with unilateral below knee bypass are acceptable for inclusion (no other concomitant surgery)
    2) Along with the below knee bypass surgery (or within the last four weeks before this surgery) the only additional vascular intervention allowed is an endovascular procedure on the opposite leg at the femoral level or below.
    3) Previous intervention (surgical or endovascular) on the aorta or below (for both legs) is not an exclusion criterion if performed at least 4 weeks before randomisation.
    4) An open-label clopidrogel washout period of at least 10 days prior to the day of randomisation should be respected for patient inclusion in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is defined as the first occurrence, over the duration of follow-up of the following cluster:
    - 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 defined as 2cm proximal or distal to the bypass graft anastomosis (graft replacement or endovascular intervention) or
    - Amputation above the ankle of the affected limb or
    - Death
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    event-driven trial (193 expected events)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-02-10. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1300
    F.4.2.2In the whole clinical trial 1460
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not applicable
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-08-05
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