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    The EU Clinical Trials Register currently displays   44020   clinical trials with a EudraCT protocol, of which   7318   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:2006-003745-16
    Sponsor's Protocol Code Number:3639a
    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:2008-09-02
    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 number2006-003745-16
    A.3Full title of the trial
    Assessment of platelet-dependent thrombosis by an ex vivo arterial injury model: a placebo controlled trial of Clopidogrel as antiplatelet therapy in patients with type 2 diabetes mellitus and coronary artery disease.
    A.3.2Name or abbreviated title of the trial where available
    Platelet-dependent thrombosis: a placebo-controlled trial of antiplatelet therapy (Clopidogrel)
    A.4.1Sponsor's protocol code number3639a
    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 SponsorNewcastle upon Tyne Hospitals NHS Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name PLAVIX
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pharma Bristol-Myers Squibb SNC
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNclopidogrel hydrogen sulphate 97.875mg (molar equivalent of 75mg of clopidogrel base)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.3.11.13.1Other medicinal product typeClopidogrel inhibits platelet aggregation by blocking the binding of adenosine diphosphate (ADP) to its platelet receptor. It is licenced for use in acute coronary syndromes.
    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 placeboCapsule*
    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
    Type 2 Diabetes Mellitus and Coronary Artery Disease
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of Clopidogrel in reduction of thrombogenicity in patients with Type 2 Diabetes Mellitus (T2DM) and Coronary Artery Disease (CAD), using an ex vivo arterial injury model.
    E.2.2Secondary objectives of the trial
    1. To identify patients (in particular T2DM patients with CAD) resistant to oral antiplatelet therapy
    2. To characterise features in T2DM patients responsible for increased thrombogenicity

    In an add-on sub-study, to test the hypotheses:
    1.the currently recommended doses of aspirin (75 mg) plus clopidogrel (75 mg) inhibit platelet-dependent thrombus formation more powerfully in subjects aged >75 years than in younger individuals
    2.in the presence of diabetes, the effect of age is reduced
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Ageing add-on non-randomised (open label) sub-study (25th Jan 2010)


    to test the hypotheses:
    1.the currently recommended doses of aspirin (75 mg) plus clopidogrel (75 mg) inhibit platelet-dependent thrombus formation more powerfully in subjects aged >75 years than in younger individuals
    2.in the presence of diabetes, the effect of age is reduced

    Three additional groups of patients, all with coronary artery disease and taking aspirin 75 mg daily routinely, will be recruited:
    1. aged >75 years, without diabetes (n=45)
    2. aged >75 years, with Type 2 diabetes (n=45)
    3. aged ≤75 years, without diabetes (n=45)

    All will receive clopidegrol 75mg daily for 7 days. In all other respects the design of the study is the same as for the main trial.
    E.3Principal inclusion criteria
    1. Patients with type 2 diabetes mellitus as defined below:
    Clinical Definitions
    T2DM: Diagnosed according to the WHO criteria
    CAD: Presence of any one of the following: Angina plus positive exercise tolerance test; enzyme and/or Q wave positive myocardial infarction; angiographic evidence (>50% stenosis of one vessel); percutaneous or surgical coronary revascularisation.
    2. Aged between 18 and 75 (main study), aged 18 years and over (add-on sub-study)
    3. Provided written consent for participation in the trial prior to any study-specific procedures or requirements.
    E.4Principal exclusion criteria
    1. Contraindication to Clopidogrel, as per Summary of Product Characteristics
    2. Smoking
    3. Malignancy
    4. Haematological disorders (Anaemia, malignancy, bleeding disorders)
    5. Women of child-bearing potential
    6. Use of corticosteroids / other antithrombotic agents
    7. Chronic liver disease (Cirrhosis, malignancy and patients with abnormal liver function tests)
    8. Unable to consent
    9. Use of investigational study drugs within 1 year prior to study entry
    10. Previous participation in this study
    E.5 End points
    E.5.1Primary end point(s)
    Change in aorta thrombus area from baseline to final visit (i.e. over 7 days) calculated by computerised planimetry using Image-Pro Plus software (results are given as the mean of the analysed sections in u2 /mm).
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    The main trial is double-blind; in addition, there is an open-label sub-study.
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of study will be the last participant's final study contact, at visit 2 (Day 8).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.6.1Details of subjects incapable of giving consent
    If potential participants have the capacity to give informed consent, but are unable to sign/date the consent form, oral consent, in the presence of an independent witness will be taken and the independent witness will sign and date the consent form.
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state225
    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)
    Normal treatment will continue
    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 Decision2008-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-31
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