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    Summary
    EudraCT Number:2015-001574-18
    Sponsor's Protocol Code Number:ESR-14-10076
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-27
    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 number2015-001574-18
    A.3Full title of the trial
    TICAGRELOR IN PATIENTS WITH STABLE ISCHEMIC HEART DESEASE WITH ELEVATION OF TROPONIN
    TICAGRELOR NELLA CARDIOPATIA ISCHEMICA STABILE IN PAZIENTI CON ELEVAZIONE DI TROPONINA - STUDIO TICIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TICAGRELOR IN PATIENTS WITH STABLE ISCHEMIC HEART DESEASE WITH ELEVATION OF TROPONIN
    TICAGRELOR NELLA CARDIOPATIA ISCHEMICA STABILE IN PAZIENTI CON ELEVAZIONE DI TROPONINA - STUDIO TICIS
    A.3.2Name or abbreviated title of the trial where available
    TICIS
    TICIS
    A.4.1Sponsor's protocol code numberESR-14-10076
    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 SponsorAZIENDA UNITÀ SANITARIA LOCALE DELLA ROMAGNA
    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 supportAUSL ROMAGNA - U.O. CARDIOLOGIA FORLI
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAUSL ROMAGNA
    B.5.2Functional name of contact pointU.O CARDIOLOGIA FORLI
    B.5.3 Address:
    B.5.3.1Street AddressVIA C. FORLANINI 34
    B.5.3.2Town/ cityFORLI
    B.5.3.3Post code47121
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 0543 735212
    B.5.5Fax number+39 0543 738640
    B.5.6E-mailmarcello.galvani@auslromagna.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 - 90 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER(PVC/PVDC/ALU) 60 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA AB
    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.3.1Product nameTicagrelor
    D.3.2Product code B01AC24
    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.3.9.2Current sponsor codeAZD6140
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 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 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
    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
    patients with stable ischemic heart disease with elevation of troponin
    PAZIENTI AFFETTI DA CARDIOPATIA ISCHEMICA CRONICA STABILECON AUMEN TO DEI VALORI DI TROPONINA
    E.1.1.1Medical condition in easily understood language
    patients with stable ischemic heart disease with elevation of troponin
    PAZIENTI AFFETTI DA CARDIOPATIA ISCHEMICA CRONICA STABILECON AUMEN TO DEI VALORI DI TROPONINA
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10055218
    E.1.2Term Ischemic heart disease
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The reduction of the mean levels of hsTnT concentrations at the end of the study period in patient treated with Ticagrelor.
    valutare se nei pazienti con cardiopatia ischemica stabile con danno miocardico il trattamento per 28 giorni con Ticagrelor in associazione a Cardioaspirin ¿ in grado di ridurre i livelli ematici di troponina T ad alta sensibilit¿ rispetto al trattamento con sola Cardioaspirin
    E.2.2Secondary objectives of the trial
    - The reduction of the percentage of patients treated with Ticagrelor with hsTnT elevations
    - The reduction of the percentage of patients treated with Ticagrelor with hsTnI elevations
    - The reduction of the mean levels of hsTnI concentrations at the end of the study period.
    - valutare se nei pazienti con cardiopatia ischemica stabile con danno miocardico il trattamento per 28 giorni con Ticagrelor ¿ in grado di ridurre i livelli ematici di troponina I ad alta sensibilit¿.
    - valutare la percentuale di pazienti con cardiopatia ischemica stabile con danno miocardico trattati per 28 giorni con Ticagrelor in cui si ha una riduzione dei valori di troponina T ad alta sensibilit¿.
    - valutare la percentuale di pazienti con cardiopatia ischemica stabile con danno miocardico trattati per 28 giorni con Ticagrelor in cui si ha una riduzione dei valori di troponina I ad alta sensibilit¿.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: We shall explore whether the fall of hsTnT concentrations within the 99th percentile at the end of the study period, both in patients treated with ticagrelor or placebo, is associated with a distinctive plaque morphology at computed tomography (CT) angiography (only in those patients with this examination available at baseline).

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Nei pazienti trattati con Ticagrelor o placebo che eseguiranno la coronaroTc prima dell'arruolamento verr¿ valutato se la riduzione dei valori di Troponina T-hs entro il 99¿ percentile correla con una particolare morfologia della placca aterosclerotica documentata mediante coronaroTc.
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures
    2. Female and male aged >18 years
    3. Stable exertional angina (Class I or II according to the Canadian Cardiovascular Society classification) without significant variation in the preceding 2 months, associated with objective evidence of myocardial ischemia consisting of ischemia on a stress imaging test with nuclear myocardial perfusion, echo or cardiac
    magnetic resonance wall motion, or cardiac magnetic resonance perfusion or with the finding of significant coronary obstructions (>50% reduction of luminal diameter of a major epicardial vessel) on coronary computed tomography angiography (CCTA) or,
    4. At least moderate ischemia on a stress imaging test with nuclear myocardial perfusion (=10% myocardium), echo or cardiac magnetic resonance wall motion (=3/16 segments with stress-induced severe hypokinesis or akinesis), or cardiac
    magnetic resonance perfusion (=12% myocardium), or the finding of severe
    coronary obstructions (>70% reduction of luminal diameter of a major epicardial vessel on CCTA) in patients without symptoms attributable to myocardial ischemia
    or,
    5. Spontaneous myocardial infarction 1 to 3 years before enrollment, and one of the
    following additional high-risk features: age =65 years, diabetes mellitus requiring
    medication, a second prior spontaneous myocardial infarction, multivessel coronary
    artery disease, or chronic renal dysfunction, defined as an estimated creatinine clearance of less than 60 ml per minute.
    6. Biochemical evidence of myocardial injury (hsTnT= 14 ng/L in male, =10 ng/L in females).
    7. Absence of contra-indications to ticagrelor .
    8. Participant is willing to comply with all aspects of the protocol, including adherence to medical therapy and follow-up visits.
    9. Treatment with ASA at a dose of 75 to 150 mg daily is mandatory in all patients
    Firma del consenso informato
    - Età=18 anni
    - Angina stabile in assenza di variazioni dei sintomi nei due mesi antecedenti associata a evidenza strumentale di ischemia documentata mediante scintigrafia miocardica o ecostress o RMN cardiaca con stress alla dobutamina, o mediante studio RMN della perfusione miocardica da stress, o documentazione di stenosi del circolo coronarico superiori al 50% mediante coronaroTc; oppure
    - Documentazione di ischemia moderata alla scintigrafia miocardica da sforzo (= 10%), all'ecostress/RMN cardiaca con stress farmacologico (=3/16 segmenti con ipocinesia o acinesia indotte da stress farmacologico), o studio RM della perfusione micoardica da stress (=12% del miocardio), o riscontro di stenosi emodinamicamente significative (>70%) alla coronaroTc.
    - Evidenza di danno miocardico: valori di troponina T-hs superiori a 14 ng/L negli uomini e superiori a 10 ng/L nelle donne.
    - Assenza di controindicazioni al Ticagrelor.
    - Volontà del partecipante a rispettare tutti gli aspetti del protocollo, compresa l'adesione alla terapia medica e alle visite di follow-up.
    - Terapia con Cardioaspirin alla posologia di 75-150 mg/die.

    E.4Principal exclusion criteria
    1- Age >75 years.
    2- Clinical heart failure.
    2- LV ejection fraction <50% or regional wall motion abnormalities at echocardiography.
    3- Severe chronic kidney disease (glomerular filtration rate < 30 ml/min/1.73 m2 measured with the Modification of Diet in Renal Disease (MDRD) Study Equation).
    4- Unacceptable level of angina despite maximal medical therapy.
    5- Very dissatisfied with medical management of angina.
    6- History of noncompliance with medical therapy.
    7- Acute coronary syndrome within the previous 6 months.
    8- Percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within the previous 12 months.
    9- Stroke within the previous 6 months or intracranial hemorrhage at any time.
    10- History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia.
    11- Planned major surgery necessitating interruption of dual antiplatelet therapy.
    12- Need for oral anticoagulation therapy or dual antiplatelet therapy.
    13- An increased risk of bradycardia.
    14- Concomitant therapy with a strong cytochrome P-450 3A4 inhibitor or inducer.
    14- Pregnancy.
    15- Inability to comply with the protocol.
    Età>75 anni
    - Scompenso cardiaco
    - Frazione d'eiezione del ventricolo sinistro<50% o presenza di anomalie della cinetica segmentaria all'ecocardiogramma
    - IRC di grado severo (VFG<30 ml/min/1.73 mq misurata mediante MDRD, the Modification of Diet in Renal Disease Study Equation)
    - Livelli di angina inaccettabili nonostante terapia medica ottimale.
    - Persistenza di livelli di angina non soddisfacenti nonostante terapia medica
    - Storia di scarsa compliance alla terapia medica.
    - Sdr. coronarica acuta nei precedenti sei mesi.
    - Angioplastica percutanea o intervento di bypass aortocoronarico nei precedenti 12 mesi.
    - Stroke nei precedenti 6 mesi o emorragia intracranica pregressa
    - Storia di tachicardia ventricolare interrotta farmacologicamente o mediante DC-shock o storia di tachicardia ventricolare sostenuta sintomatica.
    - Intervento di chirurgia maggiore già programmato con necessità di interruzione della duplice terapia antiaggregante orale.
    - Necessità di terapia anticoagulante orale o duplice terapia antiaggregante.
    - Rischio aumentato di bradicardia.
    - Terapia concomitante con inibitore o induttore del citocromo P-450 3A4
    - Gravidanza
    - Assenza di compliance al protocollo
    E.5 End points
    E.5.1Primary end point(s)
    It is expected that the mean hsTnT concentration at baseline will be 30 +/- 15 ng/L and that it will decrease to 15 +/- 10 ng/L at the end of the study. This 50% reduction in Tn levels is based on the biological variability of the hsTn assay in stable CAD patients and can be considered clinically meaningful given the long-term biological variability of hsTnT levels as assessed by the reference change value which is 32% for the hsTnT Roche assay as assessed in patients with stable CAD
    Nei pazienti trattati con Ticagrelor e Cardioaspirin ci si attende una riduzione del 50% dei valori di medi troponina T-hs rispetto ai valori basali (da 30±15 ng/L a 15±10 ng/L).
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 giorni
    E.5.2Secondary end point(s)
    - The reduction of the percentage of patients with hsTnT elevations from 100% at baseline to 50% at the end of the study period.
    -The reduction of the percentage of patients with hsTnI elevations from 100% at baseline to 50% at the end of the study period.
    - The reduction of the mean levels of hsTnI concentrations at the end of the study period. It is expected that the mean hsTnI concentration at baseline will be 70 +/- 30 ng/L and that it will decrease to 40 +/- 30 ng/L at the end of the study. This 45% reduction can be considered clinically meaningful given the biological variability of Abbott hsTnI levels, as assessed by the reference change value, which is 49% at long term in patients with stable ischemic heart disease
    al termine del periodo di studio si attende una riduzione del 50% del numero di pazienti con valori elevati di troponina T-hs;
    - al termine del periodo di studio si attende una riduzione del 50% del numero di pazienti con valori elevati di troponina I-hs;
    - nei pazienti trattati con Ticagrelor e Cardioaspirin ci si attende una riduzione del 45% dei valori medi di troponina I-hs rispetto ai valori basali (da 70¿30 ng/L a 40¿30 ng/L).
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    28 giorni
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.2.4Number 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.8.5.1Number of sites anticipated in the EEA1
    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
    LVLS
    LVLS
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    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 state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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)
    Usual care for ischemic heart disease
    Trattamentl standard della cardiopatia ischemica cronica
    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 Decision2016-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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