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    Summary
    EudraCT Number:2006-000313-38
    Sponsor's Protocol Code Number:EFC5965
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-17
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2006-000313-38
    A.3Full title of the trial
    Randomized, multinational, double-blind study, comparing a high loading dose regimen of clopidogrel versus standard dose in patients with unstable angina or myocardial infarction managed with an early invasive strategy.
    A.3.2Name or abbreviated title of the trial where available
    CURRENT
    A.4.1Sponsor's protocol code numberEFC5965
    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-aventis Recherche & Développement
    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 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 AuthorisationUnited States
    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 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
    D.3.9.1CAS number 120202-66-6
    D.3.9.2Current sponsor codeSR25990C
    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 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 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 No
    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 placeboCoated 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
    Patients with non-ST segment elevation myocardial infarction (NSTEMI), or ST segment myocardial infarction (STEMI) managed with an early PCI.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10064347
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether a high dose regimen of clopidogrel (600 mg loading dose [LD] followed by 150 mg once daily (o.d) from Day 2 to 7, then 75 mg o.d) is superior to a standard dose of clopidogrel (300 mg LD followed by 75 mg o.d) in preventing the composite of cardiovascular death, MI or stroke in acute coronary syndromes (ACS) patients with unstable angina (UA) or non-ST segment elevation myocardial infarction (NSTEMI), or ST segment myocardial infarction (STEMI), who are treated with an early invasive strategy with an intent to perform a PCI as early as possible and no later than 72 hours of randomization.

    Also to determine, in a factorial design, whether a high dose of acetylsalicylic acid (ASA) is superior to a low dose ASA in preventing the composite of cardiovascular death, MI or stroke.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of the clopidogrel high dose regimen compared to the standard dose regimen in terms of major bleeding (i.e. severe bleeding and other major bleeding).
    To evaluate the safety of the ASA high dose regimen (300-325 mg) compared to the low dose (75-100 mg) regimen in terms of major bleeding (i.e. severe bleeding and other major bleeding) and the net efficacy to safety balance of death or MI or stroke to major bleeding.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Full title of the sub-study : Effect of type of access for PCI (Radial or Femoral) on bleeding rate.

    Date : 2006-11-21

    Version : 02

    Sub-study objectives :
    - To determine if a trans-radial access approach is superior to a trans-femoral access site approach in terms of reducing major bleeding, need for blood transfusion and vascular access site complications.
    - To compare ischemic complications, including death, MI and stroke between a trans-radial versus a trans-femoral approah.
    - To compare each strategy in terms of duration of the procedure, amount of contrast dye used, proportion of patients developing contrast induced nephropathy, need for conversion to an alternative access route and costs incurred.
    - To determine if radial artery access site procedures lead to shorter hospital stays compared with femoral access site procedures.
    E.3Principal inclusion criteria
    1. ACS patients

    1.1 UA/NSTEMI patients: Ischemic symptoms suspected to represent a non-ST segment elevation ACS (unstable angina [UA] or non-ST segment elevation myocardial infarction [NSTEMI]) defined as:
    Clinical history consistent with new onset, or a worsening pattern, of characteristic
    ischemic chest pain occurring at rest or with minimal exertion (lasting longer than
    10 minutes) and planned to be managed with an early invasive strategy with intent
    to perform a percutaneous coronary intervention (PCI) as early as possible and no
    later than 72 hours of randomization.
    AND at least one of the following
    a) Electrocardiogram (ECG) changes compatible with new ischemia [ST depression of at least 1 mm or transient ST elevation or ST elevation of less than or equal to 1 mm or T wave inversion greater than 3 mm in at least 2 contiguous leads].
    or
    b) Already elevated cardiac enzymes (e.g. CKMB) or biomarkers (troponin I or T) above the upper limit of normal.
    OR
    1.2 STEMI patients:
    a) Presenting with signs or symptoms of acute myocardial infarction lasting at least 20 minutes and planned to be managed with an early invasive strategy, i.e. with an intent to perform a percutaneaous coronary intervention (PCI) as early as possible and no later than 72 hours of randomization (this may include either primary PCI or initial management with medical therapy).
    b) Definite ECG changes compatible with STEMI persistent ST-elevation (≥2mm in two contiguous precordial leads, or > 1mm in at least two limb leads) new left bundle branch block or Q wave in 2 contiguous leads.

    2. Randomized within 24 hours of onset of the most recent episode of chest pain or symptoms consistent with ischemia/infarction.

    3. Written informed consent.
    E.4Principal exclusion criteria
    1. Age < 18 years.
    2. Use of oral anticoagulants within the last 10 days with an INR > 1.5 or planned use during the hospitalization period.
    3. Administration of clopidogrel > 75 mg within 24 hours prior to randomization.
    4. Contraindication to the use of clopidogrel and/or ASA:
    • History of drug allergy to thienopyridine derivatives or ASA
    • History of clinically significant or persistent thrombocytopenia or neutropenia
    5. Active bleeding or significant increased risk of bleeding, such as elderly patients receiving fibrinolytic therapy and other potent antithrombotic agents, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
    6. History of severe systemic bleeding (e.g. gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, or intracranial hemorrhage), or other history of bleeding diathesis or coagulopathy.
    7. Uncontrolled hypertension.
    8. Previously entered in the study.
    9. Investigational treatment (drug or device) within the previous 30 days.
    10. Medical, geographic, or social factors making study participation impractical, or inability to provide written informed consent and to understand the full meaning of the informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    PRIMARY ENDPOINTS FOR CLOPIDOGREL DOSE COMPARISONS:
    First efficacy endpoint:
    First occurrence of any component of the composite cluster of cardiovascular (CV) death, MI or stroke at 30 Days.
    Primary safety endpoint:
    Major bleeding (i.e. severe bleeding and other major bleeding) at 30 Days.

    PRIMARY ENDPOINTS FOR ASA DOSE COMPARISONS:
    Primary efficacy endpoint:
    First occurrence of any component of the composite cluster of cardiovascular (CV) death, MI or stroke at 30 Days.
    Safety endpoint:
    Major bleeding (i.e. severe bleeding and other major bleeding) at 30 days.
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA229
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    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 2006-10-17. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    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 state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 9627
    F.4.2.2In the whole clinical trial 25000
    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 Decision2006-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-31
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