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    Summary
    EudraCT Number:2012-003897-21
    Sponsor's Protocol Code Number:1525/12
    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:2012-12-28
    Trial 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 number2012-003897-21
    A.3Full title of the trial
    Effects of TIcaGREloR on Circulating Microparticles and Micro-RNAs in patients with Non ST Elevation Acute Coronary Syndromes
    Effetto del TIcaGREloR sulle Microparticelle Circolanti e sui Micro-RNAs nei pazienti con Sindrome Coronarica Acuta senza Sopraslivellamento del Tratto ST
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of TIcaGREloR on Circulating Microparticles and Micro-RNAs in patients with Non ST Elevation Acute Coronary Syndromes
    Effetto del TIcaGREloR sulle Microparticelle Circolanti e sui Micro-RNAs nei pazienti con Sindrome Coronarica Acuta senza Sopraslivellamento del Tratto ST
    A.3.2Name or abbreviated title of the trial where available
    TIGER-M study
    TIGER-M study
    A.4.1Sponsor's protocol code number1525/12
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    B.1.3.4CountryItaly
    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 supportAstrazeneca
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPOLICLINICO GEMELLI
    B.5.2Functional name of contact pointTERAPIA SUBINTENSIVA CARDIOLOGICA
    B.5.3 Address:
    B.5.3.1Street AddressLGO GEMELLI 8
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630154109
    B.5.5Fax number06 3055535
    B.5.6E-mailLMARZIO.BIASUCCI@RM.UNICATT.IT
    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 BRILIQUE*60CPR RIV 90MG
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 No
    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 INNTICAGRELOR
    D.3.9.1CAS number 274693-27-5
    D.3.9.4EV Substance CodeSUB30898
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 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*28CPR RIV 75MG
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 No
    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 113665-84-2
    D.3.9.4EV Substance CodeSUB13395MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non ST Elevation Acute Coronary Syndromes
    SINDROME CORONARICA ACUTA SENZA SOPRASLIVELLAMENTO DEL TRATTO ST
    E.1.1.1Medical condition in easily understood language
    Non ST Elevation Acute Coronary Syndromes
    SINDROME CORONARICA ACUTA SENZA SOPRASLIVELLAMENTO DEL TRATTO ST
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10051592
    E.1.2Term Acute coronary syndrome
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to assess MP levels variation in Non ST-Elevation Acute Coronary Syndromes (NSTE-ACS) patients treated with ticagrelor in addition to low or high acetyl-salicylic acid (ASA), in comparison with clopidogrel+ASA treatment, to demonstrate that major clinical efficacy of ticagrelor could be partially attributed to its influence on release of MP, that have an important role in coronary instability.
    Valutare la variazione nel tempo dei livelli ematici delle Microparticelle (MP) nei pazienti con Sindromi coronariche acute senza sopraslivellamento del tratto ST (Non-ST Elevation 10 Acute Coronary Syndrome -NSTE-ACS) trattati con ticagrelor in associazione all’acido acetilsalicilico (ASA), rispetto alla doppia terapia anti-aggregante costituita da clopidogrel e ASA, per dimostrare che la maggiore efficacia clinica del ticagrelor potrebbe essere parzialmente attribuita alla sua influenza sul rilascio di MP, le quali esercitano un ruolo importante nell’instabilità coronarica.
    E.2.2Secondary objectives of the trial
    - to evaluate microRNAs levels variation in Non ST-Elevation Acute Coronary Syndromes (NSTE-ACS) patients treated with ticagrelor in addition to low or high ASA, in comparison with clopidogrel+ASA treatment, and to study possible correlation between microRNAs and MP levels, supposing that the ability of ticagrelor in reduced MP level could be related with microRNAs expression.
    Valutare la variazione nel tempo dei livelli di microRNA nei pazienti con Sindromi coronariche acute senza sopraslivellamento del tratto ST (Non-ST Elevation Acute Coronary Syndrome -NSTE-ACS) trattati con ticagrelor in associazione all’acido acetilsalicilico (ASA), rispetto alla doppia terapia anti-aggregante costituita da clopidogrel e ASA, e studiare una possibile correlazione tra i livelli di microRNA e di MP, supponendo che la capacità del ticagrelor nel ridurre i livelli di MP potrebbe essere correlata con l'espressione di microRNA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -PATIENT WITH NON-ST ELEVATION ACUTE CORONARY SYNDROMES - men aged between 50 and 80 years - postmenopausal women
    pazienti con sdr coronarica acuta senza sopraslivellamento del tratto ST. Uomini di età compresa tra 50 e 80 anni - Donne in età postmenopausale
    E.4Principal exclusion criteria
    men aged <50 years or >80 years - impossibility to give informed consent - women of childbearing age - diabetes mellitus - severe renal failure (CrCl < 30 ml/min) - infective, neoplastic or autoimmune diseases - ACS and /or TIA/stroke in the previous three months - trauma or surgical operations in the previous three months - active hemorrhage - fibrinolytic therapy within 24 hours before randomization, - a need for oral anticoagulation therapy - an increased risk of bradycardia - drugs study hypersensitivity (including aspirin) - moderate to severe hepatic impairment 15 - co-administration of ticagrelor or clopidogrel with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir)
    GRACE RISK SCORE >140
    In stent restenosis
    Uomini di età inferiore ai 50 anni o superiore agli 80 anni - Impossibilità a dare il consenso informato 12 - Donne in età fertile - Diabete mellito - Insufficienza renale cronica di grado severo (CrCl &lt; 30 ml/min) - Malattie infettive, neoplastiche o autoimmuni - Sindromi coronariche acute e/o eventi cerebrovascolari nei tre mesi precedenti all’arruolamento - Trauma o interventi chirurgici nei tre mesi precedenti all’arruolamento - Emorragie attive - Terapia fibrinolitica nelle 24 ore precedenti all’arruolamento - Necessità di terapia anticoagulante orale - Aumentato rischio di bradiaritmie - Allergia/intolleranza ai farmaci coinvolti nello studio (inclusa l’aspirina) - Insufficienza epatica di grado moderato-severo - Somministrazione di potenti inibitori del citocromo CYP3A4 (es: ketoconazolo, claritromicina, nefazodone, ritonavir, e atazanavir)
    pazienti con GRACE RISK SCORE elevato (&gt;140)
    Restenosi in stent
    E.5 End points
    E.5.1Primary end point(s)
    MP levels variation
    dosaggio livelli MP
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 Months
    3 mesi
    E.5.2Secondary end point(s)
    evaluate microRNAs levels
    dosaggio livelli microRNA
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 Months
    3 mesi
    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 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) 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 Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 No
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years24
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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.1.2.1Number of subjects for this age range: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state64
    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)
    routine treatment
    routine clinica
    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 Decision2013-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
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