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    Summary
    EudraCT Number:2014-005498-35
    Sponsor's Protocol Code Number:ISSBRIL0345
    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:2020-11-05
    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 number2014-005498-35
    A.3Full title of the trial
    TWILIGHT Study
    Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary
    Intervention
    TWILIGHT
    Ticagrelor Con Aspirina o Da Solo In Pazienti Ad Alto Rischio Dopo
    Intervento Coronarico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TWILIGHT Study
    Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary
    Intervention
    TWILIGHT
    Ticagrelor Con Aspirina o Da Solo In Pazienti Ad Alto Rischio Dopo
    Intervento Coronarico
    A.3.2Name or abbreviated title of the trial where available
    TWILIGHT
    TWILIGHT
    A.4.1Sponsor's protocol code numberISSBRIL0345
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02270242
    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 SponsorINTERVENTIONAL CARDIOVASC. RESEARCH & CLINICAL TRIALS AT ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
    B.1.3.4CountryUnited States
    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 supportCardiovascular Office Mount Sinai
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCardiovascular Office of Mount Sinai
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressOne Gustave L. Levy Place, Box 1030
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10029-6574
    B.5.3.4CountryUnited States
    B.5.4Telephone number0012126598372
    B.5.5Fax number0016465378547
    B.5.6E-mailTWILIGHTStudy@mountsinai.org
    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 Praxis ASA EC 81 mg Daily Low Dose
    D.2.1.1.2Name of the Marketing Authorisation holderPharmascience Inc
    D.2.1.2Country which granted the Marketing AuthorisationCanada
    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 nameAcetylsalicylic acid
    D.3.2Product code [Praxis ASA EC]
    D.3.4Pharmaceutical form 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.3.9.1CAS number 50-78-2
    D.3.9.2Current sponsor codeNon applicabile
    D.3.9.3Other descriptive nameAcetylsalicylic Acid
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number81
    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 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
    Bleeding among high-risk patients with percutanous coronary intervention with at least one drug-eluting stent
    pazienti ad alto rischio di sanguinamento che sono stati sottoposti con successo a PCI con almeno uno stent a rilascio di farmaco
    E.1.1.1Medical condition in easily understood language
    Bleeding among high-risk patients with percutanous coronary intervention with at least one drug-eluting stent
    pazienti ad alto rischio di sanguinamento che sono stati sottoposti con successo a PCI con almeno uno stent a rilascio di farmaco
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10065608
    E.1.2Term Percutaneous coronary intervention
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 determine the impact of antiplatelet monotherapy with ticagrelor alone versus Dual Antiplatelet Therapy (DAPT) with ticagrelor plus aspirin for 12 months in reducing clinically relevant bleeding among high-risk patients undergoing PCI who have completed a 3-month course of aspirin plus ticagrelor.
    L'obiettivo primario di questo studio è di determinare l'effetto della monoterapia anti-aggregante con ticagrelor da solo rispetto alla DAPT con ticagrelor e aspirina per 12 mesi nel ridurre la comparsa di sanguinamento clinicamente significativo in pazienti ad alto rischio che sono stati sottoposti con successo a PCI e che hanno completato un ciclo di tre mesi di DAPT con aspirina e ticagrelor.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to determine the impact of antiplatelet monotherapy with ticagrelor alone versus DAPT with ticagrelor plus aspirin for 12 months in reducing major ischemic adverse events among high-risk patients undergoing PCI who have completed a 3-month course of aspirin plus ticagrelor.
    L'obiettivo secondario di questo studio è di determinare l'effetto della monoterapia anti-aggregante con
    ticagrelor da solo rispetto alla DAPT con ticagrelor e aspirina per 12 mesi nel ridurre eventi avversi maggiori di tipo ischemico in pazienti ad alto rischio che sono stati sottoposti con successo a PCI e che hanno completato un ciclo di tre mesi di DAPT con aspirina e ticagrelor.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Must meet AT LEAST ONE clinical inclusion criterion:
    - Adult patients = 65 years of age
    - Female gender
    - Troponin positive acute coronary syndrome
    - Established vascular disease defined as previous MI, documented PAD or CAD/PAD revascularization
    - Diabetes mellitus treated with medications or insulin
    - Chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2 or creatinine clearance (CrCl) <60 ml/min
    Must meet AT LEAST ONE angiographic inclusion criterion:
    - Multivessel coronary artery disease (CAD)
    - Target lesion requiring total stent length >30mm
    - Thrombotic target lesion(s)
    - Bifurcation lesion(s) with Medina X,1,1 classification requiring at least 2 stents
    - Left main (=50%) or proximal LAD (=70%) lesion
    - Calcified target lesion(s) requiring atherectomy
    L'arruolamento nello studio richiederà la presenza di almeno un criterio clinico di inclusione:
    - Pazienti adulti di età = 65 anni
    - Sesso femminile
    - Sindrome coronarica acuta con Troponina positiva
    - Malattia Vascolare Documentata
    - Diabete mellito che richiede terapia
    - CKD (eGFR < 60 ml/min/1.73m2 o CrCl < 60ml/min)
    L'arruolamento nello studio richiederà la presenza di almeno un criterio angiografico:
    - CAD multi-distrettuale
    - Lesione(i) che richiedono il posizionamento di stent per una lunghezza totale > 30 mm
    - Lesioni trombotiche
    - Lesione ad una biforcazione (x,1,1) che richiede almeno 2 stents
    - Lesione (=50%) della coronaria sinistra principale o Lesione (=70%) della LAD prossimale
    - Indicazione ad aterectomia di lesione(i) calcificata
    E.4Principal exclusion criteria
    Subjects should not enter the study if any of the following exclusion criteria are met:
    - Under 18 years of age
    - Contraindication to aspirin, as listed in Appendix D
    - Contraindication to ticagrelor, as listed in Appendix E
    - Planned surgery within 90 days
    - Planned coronary revascularization (surgical or percutaneous) within 90 days
    - Need for chronic oral anticoagulation
    - Prior stroke
    - Dialysis-dependent renal failure
    - Active bleeding or extreme-risk for major bleeding (e.g. acute gastrointestinal ulcer or history of chronic gastrointestinal ulceration, gastrointestinal pathology with a raised risk for bleeding, malignancies with a raised risk for bleeding)
    - Salvage PCI or STEMI presentation.
    - Liver cirrhosis
    - Life expectancy < 1 year
    - Unable or unwilling to provide informed consent
    - Women of child bearing potential as defined below:
    A woman is considered of childbearing potential (WOBCP) following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
    - Fibrinolytic therapy within 24 hours of index PCI
    - Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
    - Platelet count < 100,000 mm3
    - Requiring ongoing treatment with aspirin =325 mg daily
    L'arruolamento nello studio richiederà la presenza di nessuno dei seguenti criteri di esclusione:
    - Età < 18 anni
    - Controindicazione all'Aspirina, come elencato nell'Appendice D
    - Controindicazione al Ticagrelor, come elencato in Appendice E
    - Intervento chirurgico programmato entro 90 giorni
    - Rivascolarizzazione coronarica programmata (chirurgica o percutanea) entro 90 giorni
    - Necessità di terapia anticoagulante orale cronica
    - Pregresso infarto
    - Insufficienza renale dialisidipendente
    - Sanguinamento attivo o rischio estremo di sanguinamento maggiore
    - PCI di salvataggio o presentazione con STEMI
    - Cirrosi Epatica
    - Aspettativa di vita < 1 anno
    - Mancanza di abilità o volontà di firmare il consenso informato
    - Donne potenzialmente in età fertile come definito di seguito: una donna è considerata in potenziale età fertile dopo il menarca e prima dell'inizio della menopausa in assenza di sterilità permanente. Metodi di sterilizzazione permanente sono isterectomia, salpingectomia bilaterale e ovariectomia bilaterale. Si definisce post menopausa la condizione in cui non ci sia presenza del ciclo mestruale per 12 mesi senza cause mediche.
    - Terapia fibrinolitica entro 24 ore dalla PCI iniziale
    - Concomitante terapia con un forte inibitore o induttore del citocromo P-450 3A
    - Conta piastrinica < 100,000 mm3
    - Necessità attuale di trattamento con aspirina = 325 mg al giorno
    E.5 End points
    E.5.1Primary end point(s)
    The primary bleeding endpoint of the present study is the time to first occurrence of clinically relevant bleeding, defined as Bleeding Academic Research Consortium (BARC) Types 2, 3 or 5 bleeding.
    The primary ischemic endpoint of the present study is the time to first occurrence of confirmed all-cause death, non-fatal myocardial infarction, or stroke.
    L'obiettivo primario è di determinare se ticagrelor monoterapia sia superiore a ticagrelor e aspirina per l'obiettivo (endpoint) primario di sanguinamento (sanguinamento BARC Tipo 2, 3, o 5).
    L'obiettivo principale è di determinare se ticagrelor monoterapia sia non-inferiore a ticagrelor e aspirina per
    l'obiettivo (endpoint) primario di ischemia (morte per tutte le cause, infarto miocardico non fatale, o ictus).
    E.5.1.1Timepoint(s) of evaluation of this end point
    time from randomisation to death or last follow-up.
    Dalla randomizzazione alla morte o ultima visita di follow-up.
    E.5.2Secondary end point(s)
    Time to first occurrence of:
    • Types 3 or 5 bleeding according to definitions from BARC
    • Minor or major bleeding according to definitions from Thrombolysis in Myocardial Infarction (TIMI)
    • Moderate or severe or life-threatening bleeding according to definitions from GUSTO
    • Major bleeding according to definitions from International Society of Thrombosis or Hemostasis (ISTH)
    Secondary Ischemic Endpoints
    • cardiovascular death, non-fatal myocardial infarction, ischemic stroke or clinically-driven revascularization
    • cardiovascular death, non-fatal myocardial infarction or ischemic stroke
    • definite or probable stent thrombosis
    • cardiovascular death
    • non-fatal myocardial infarction
    • cardiovascular death, non-fatal myocardial infarction or definite or probable stent thrombosis
    • ischemic stroke
    • all-cause mortality
    Tempo di prima rilevazione:
    - Sanguinamento di tipo 3 o 5 in accordo con la definizione di BARC
    - Sanguinamento minore o maggiore in accordo con la definizione di Trombolisi nell'Infarto Miocardico (TIMI)
    - Sanguinamento moderato o severo o rischioso per la vita in accordo con la definizione GUSTO
    - Sanguinamento maggiore in accordo con la definizione ISTH
    Endpoints ischemici secondari:
    Tempo di prima rilevazione:
    - morte per evento cardiovascolare, infarto miocardico non fatale, ictus ischemico o rivascolarizzazione indotta
    - morte per evento cardiovascolare, infarto miocardico non fatale, ictus ischemico
    - certo o probabile stent a livello trombotico
    - morte per evento cardiovascolare
    - infarto miocardico non fatale
    - morte per evento cardiovascolare, infarto miocardico non fatale o probabile o sicuro stent
    - infarto ischemico
    - tutte le cause di morte
    E.5.2.1Timepoint(s) of evaluation of this end point
    time from randomisation to death or last follow-up
    Dalla randomizzazione alla morte o ultima visita di Follow-up
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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 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 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 concerned22
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Austria
    Canada
    China
    Germany
    India
    Israel
    Italy
    Poland
    Spain
    United States
    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 years2
    E.8.9.1In the Member State concerned months3
    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 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: 5400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3600
    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 state1500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4500
    F.4.2.2In the whole clinical trial 9000
    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)
    At the End of Study visit physicians caring for the patient will decide which antiplatelet medication the patient should receive as part of his/her ongoing clinical care. This medication(s) will be open label and obtained locally
    Durante la Visita Finale il medico valuterà la tipologia di trattamento antipiastrinico che il paziente potrà ricevere. Questo trattamento sarà reso noto e somministrato presso il centro.
    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 Decision2016-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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