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    Summary
    EudraCT Number:2007-005210-39
    Sponsor's Protocol Code Number:H7T-MC-TABY(a)
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-16
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-005210-39
    A.3Full title of the trial
    Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with Unstable Angina/Non-ST-Elevation Myocardial Infarction UA/NSTEMI) Who are Medically Managed – The TRILOGY ACS Study
    A.3.2Name or abbreviated title of the trial where available
    H7T-MC-TABY(a)
    A.4.1Sponsor's protocol code numberH7T-MC-TABY(a)
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorELI LILLY
    B.1.3.4CountryItaly
    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 No
    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 nameprasugrel
    D.3.2Product code LY640315
    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 IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 389574-19-0
    D.3.9.2Current sponsor codeLY640315
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    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 No
    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 nameprasugrel
    D.3.2Product code LY640315
    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 IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 389574-19-0
    D.3.9.2Current sponsor codeLY640315
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClopidogrel
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboBuccal use
    D.8 Placebo: 2
    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 placeboBuccal use
    D.8 Placebo: 3
    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 placeboBuccal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of Acute Coronay Syndrome in medically managed subjects enrolled within 7 days of the UA/NSTEMI index event
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10051592
    E.1.2Term Acute coronary syndrome
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to test the hypothesis that prasugrel and aspirin is superior to clopidogrel and aspirin in the treatment of medically managed subjects enrolled within 7 days of the unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) index event. Superiority will be assessed by the reduction in risk of the composite endpoint of first occurrence of cardiovascular (CV) death, myocardial infarction (MI), or stroke throughout the study. The primary analysis will be conducted in a hierarchical manner, with evaluation of the primary endpoint performed first in medically managed UA/NSTEMI subjects <75 years of age. Conditional on successfully establishing superiority in the primary analysis, the same composite endpoint will be evaluated in the entire population.
    E.2.2Secondary objectives of the trial
    The following secondary endpoints will be analyzed in both the population of medically managed UA/NSTEMI subjects age < 75 years and the entire medically managed UA/NSTEMI population (subjects < age 75 years and subjects &#8805; age 75 years). The secondary efficacy objectives are to compare the prasugrel and clopidogrel groups with respect to: The risk of the composite endpoint of first occurrence of CV death and MI. The risk of the composite endpoint of first occurrence of CV death, MI, stroke, or rehospitalization for recurrent UA. The risk of the composite endpoint of first occurrence of all cause death, MI, or stroke. Safety objectives include the comparison of prasugrel with clopidogrel with respect to non-CABG related bleeding events classified according to the TIMI criteria and GUSTO definitions and overall safety and tolerability based on vital signs, laboratory values, and treatment-emergent adverse events
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    FARMACOECONOMIA: Versione:a Data:2008/02/06 Titolo:Sottostudio su gli esiti sanitari Obiettivi:Si procedera', per tutta la durata della ricerca, a una stima dei costi sanitari cumulativi facendo uso di informazioni inerenti alla fatturazione ospedaliera. La qualita' di vita sara' misurata nei soggetti al basale mediante il questionario EQ-5D e altre misure selezionate. Da un campione casuale di soggetti saranno raccolti dati di follow-up sulla qualita' di vita.

    ALTRI SOTTOSTUDI: 1) sottostudio sulla funzionalita' piastrinica (non tutti i centri vi partecipano. Fa parte del protocollo principale datato 6-feb-08. 2) prelievo e conservazione di campioni di DNA in una banca

    E.3Principal inclusion criteria
    - Male or female, 18 years of age or older who have had a UA/NSTEMI index event within 7 days (168hours) prior to randomization. - Have had a decision for medical management (that is, neither percutaneous coronary intervention [PCI] nor coronary artery bypass graft [CABG] is planned for management of the index event). This decision should be made with reasonable certainty and be based on angiography and/or the subject’s known clinical information (may include, but need not be limited to known coronary anatomy, age, or co-morbidity). For subjects whose medical management decision and randomization occurs no later than 24 hours following onset of the index event, prior clopidogrel treatment is not a consideration for eligibility. For subjects with a medical management decision who are randomized beyond 24 hours of onset of the index event, commercial clopidogrel must have been received according to standard of care practice guidelines no later than 24 hours following the onset of the index event . - Have had at least 1 of the following 3 high-risk features at the time of the UA/NSTEMI event: Age >60 years Prior MI evidenced by pre-existing Q waves, or demonstration of infarction on imaging studies, or prior documentation of elevated cardiac markers. Diabetes Mellitus - defined by concomitant treatment with an oral hypoglycemic agent and/or insulin. - Have at least 1 native coronary artery stenosis > 50% (applies only to those subjects who undergo diagnostic coronary angiography within 7 days of the onset of the index event but do not undergo PCI or CABG after angiography is performed
    E.4Principal exclusion criteria
    Cardiovascular Exclusion Criteria
    [5] Decision for medical management >24 hours after the onset of the
    index event without commercial clopidogrel treatment within 24 hours
    following the onset of the index event (Note: commercial clopidogrel
    treatment must continue daily thereafter until randomization).
    [6] Previous or planned (during the index hospitalization or thereafter)
    PCI or CABG as treatment for the index event.
    [7] PCI or CABG within the previous 30 days.
    [8] STEMI as the index event.
    [9] Cardiogenic shock within the previous 24 hours (defined as a systolic
    blood pressure <90 mm Hg associated with clinical evidence of endorgan
    hypoperfusion, or hypotension requiring vasopressors to
    maintain systolic blood pressure over 90 mm Hg and associated with
    clinical evidence of end-organ hypoperfusion).
    [10] Refractory ventricular arrhythmias within the previous 24 hours.
    [11] Symptoms of New York Heart Association (NYHA) Class IV
    congestive heart failure (CHF) within the previous 24 hours (see
    Attachment TABY.4 for NYHA CHF classifications).
    Exclusion Criteria Related to Bleeding
    [12] Contraindicated for antiplatelet therapy.
    [13] Received fibrinolytic therapy as initial treatment for the index event.
    [14] Any history of bleeding diathesis.
    [15] Clinical findings associated, in the judgment of the investigator, with
    an unacceptably high risk of bleeding.
    [16] Any of the following:
    History of ischemic or hemorrhagic stroke
    Intracranial neoplasm, arteriovenous malformation, or aneurysm
    History of any TIA symptoms.
    [17] International Normalized Ratio (INR) known to be >1.5 at the time of
    screening.
    [18] Platelet count of <100,000/mm3 at the time of screening.
    [19] Anemia (hemoglobin [Hgb] <10 gm/dL) at the time of screening.
    [20] History of spontaneous gastrointestinal bleeding requiring in-hospital
    treatment.
    [21] History of spontaneous non-gastrointestinal internal bleeding requiring
    in-hospital treatment.
    [22] Currently receiving hemodialysis or peritoneal dialysis.
    Prior/Concomitant Therapy Exclusion Criteria
    [23] History of intolerance or allergy to aspirin or approved thienopyridines
    (ticlopidine or clopidogrel).
    [24] Treated with ticlopidine within 5 days of randomization.
    [25] Receiving prasugrel treatment at the time of screening.
    [26] Receiving oral anticoagulants at the time of screening or are
    anticipated to require oral anticoagulants therapy during the course of
    the study.
    [27] Receiving daily treatment with nonsteroidal anti-inflammatory drugs
    (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be
    discontinued or are anticipated to require >2 weeks of daily treatment
    with NSAIDs or COX2 inhibitors during the study.
    General Exclusion Criteria
    [28] Unwilling to provide or not sufficiently mentally competent to provide
    written informed consent.
    [29] Study site personnel directly affiliated with the study or are immediate
    family of study site personnel directly affiliated with the study.
    Immediate family is defined as a spouse, parent, child, or sibling,
    whether biological or legally adopted.
    [30] Employed by Eli Lilly and Company, Ube Industries Limited, Daiichi
    Sankyo Pharma Inc, the academic research organization (ARO), or the
    contract research organization (CRO) (that is, employees, temporary
    contract workers, or designees responsible for the conduct of the
    study).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the time to the first occurrence of the composite of CV death, MI, or stroke.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA250
    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
    Visita dell'ultimo paziente
    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 days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    alcuni pazienti con ACS potrebbero essere troppo malati per firmare il consenso.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state370
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3500
    F.4.2.2In the whole clinical trial 11200
    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)
    Dopo il completamento o il ritiro dallo studio prasugrel non sara' fornito.Il continuamento del trattamento con clopidogrel o con altra terapia sara' a discrezione del medico curante
    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 Decision2008-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-30
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