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    Summary
    EudraCT Number:2014-000197-19
    Sponsor's Protocol Code Number:NCT02032303
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-01
    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 number2014-000197-19
    A.3Full title of the trial
    Assessment of Coronary Flow Reserve by Doppler Flow WIre in Patients With Acute Coronary Syndrome Undergoing PercuTaneous Coronary Intervention: DiffErences Between the LoAding Dose of Ticagrelor and PrasugrEl.
    Valutazione della riserva coronarica con il Doppler Flow Wire in pazienti con sindrome coronarica acuta sottoposti ad intervento coronarico percutaneo: differenze tra Ticagrelor e Prasugrel
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of improvement of the coronary flow after the administration of two different antiplatelet drugs (Ticagrelor or Prasugrel)
    Valutazione del miglioramento del flusso coronarico dopo somministrazione di due diversi antiaggreganti (Ticagrelor or Prasugrel)
    A.3.2Name or abbreviated title of the trial where available
    DELATE
    DELATE
    A.4.1Sponsor's protocol code numberNCT02032303
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02032303
    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 SponsorUMBERTO I - POLICLINICO DI ROMA
    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 supportFondi propri
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUmberto I - Policlinico di Roma
    B.5.2Functional name of contact pointEmodinamica A
    B.5.3 Address:
    B.5.3.1Street AddressViale del Policlinico, 155
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00161
    B.5.3.4CountryItaly
    B.5.4Telephone number+390649979044
    B.5.5Fax number+390649979047
    B.5.6E-mailmassimomancone@gmail.com
    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) 56 COMPRESSE (CONF. CALENDARIZZATA)
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.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 EFIENT - 10MG - COMPRESSA RIVESTITA CON FILM - USO ORALE BLISTER (ALL) 90X1 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NEDERLAND BV
    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 nameEFIENT
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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 Yes
    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
    Patients with acute coronary syndrome
    Pazienti con sindromi coronariche acute
    E.1.1.1Medical condition in easily understood language
    Patients with acute myocardial infarction and instable angina
    Pazienti con infarto miocardico acuto e angina instabile
    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 PT
    E.1.2Classification code 10028596
    E.1.2Term Myocardial infarction
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10007541
    E.1.2Term Cardiac disorders
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002388
    E.1.2Term Angina unstable
    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
    In the present study we aim to compare the adenosine induced coronary dilatation after the loading dose of Ticagrelor (180 mg) versus Prasugrel (60 mg) in patients with ACS (acute coronary syndromes) undergoing PCI (percutaneous coronary intervention).
    Valutare l'effetto coronarodilatatore indotto dopo dose di carico di
    Ticagrelor (180 mg) o Prasugrel (60 mg) in pazienti con SCA (sindromi coronariche acute) sottoposti a PCI (intervento coronarico percutaneo)
    E.2.2Secondary objectives of the trial
    Not applicable
    Nessuno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with ACS (acute coronary syndromes) undergoing PCI with
    stent implantation;
    • Patients = 18 and = 75 years old;
    • Signed informed consent.
    • Pazienti con sindromi coronariche acute sottoposti a intervento coronarico percutaneo con impianto di stent
    • Patienti = 18 e = 75 anni;
    • Consenso informato firmato.
    E.4Principal exclusion criteria
    • Patients with stable angina;
    • prior myocardial infarction;
    • prior revascularization (PCI or CABG-coronary artery bypass
    grafting);
    • Prasugrel and/or Ticagrelor contraindications (history of intracranial
    hemorrhage, active pathological bleeding, severe hepatic impairment);
    • major periprocedural complications;
    • GFR ( glomerular filtration rate) < 30 ml/min or requiring
    haemodialysis;
    • Non-sinus rhythm;
    • severe COPD (chronic obstructive pulmonary disease);
    • requirement for oral anticoagulant;
    • risk of bleeding or bradycardic events;
    • EF (ejection fraction) < 45%;
    • Cardiogenic shock;
    • Severe left ventricular hypertrophy;
    • severe valvular disease;
    • indication to CABG;
    • diffuse coronary atherosclerosis;
    - pazienti con angina stabile;
    - precedente infarto miocardico;
    - precedente rivascolarizzazione;
    - controindicazioni al prasugrel o al ticagrelor;
    - complicanze intraprocedurali maggiori;
    - GFR <30 ml/min o necessità di emodialisi;
    - ritmo non sinusale;
    - BPCO severa;
    - necessità di anticoagulanti;
    - rischio di sanguinamenti o bradicardia;
    - FE<45%;
    - shock cardiogeno;
    - severa ipertrofia del ventricolo sinistro;
    - severa valvulopatia;
    - indicazione a By-pass aortocoronarico;
    - diffusa malattia aterosclerotica
    E.5 End points
    E.5.1Primary end point(s)
    To investigate the enhancement of Adenosine-induced coronary vasodilatation in terms of max-CFR after the loading dose of Ticagrelor (180 mg) either Prasugrel (60 mg) in patients with ACS undergoing PCI, at gradually increasing doses of adenosine.
    Valutare l'effetto coronarodilatatore indotto dopo dose di carico di Ticagrelor (180 mg) o Prasugrel (60 mg) in pazienti con SCA (sindromi coronariche acute) sottoposti a PCI (intervento coronarico percutaneo)
    E.5.1.1Timepoint(s) of evaluation of this end point
    About 3 hours after the loading dose
    Circa 3 ore dopo il carico di ticagrelor o prasugrel
    E.5.2Secondary end point(s)
    To assess if higher plasmatic concentrations of Ticagrelor are related to higher CFR at gradually increasing doses of Adenosine;
    Valutare se concentrazioni plasmatiche pi¿ alte di Ticagrelor sono correlate ad una pi¿ alta CFR a dosaggi crescenti di Adenosina;
    E.5.2.1Timepoint(s) of evaluation of this end point
    About 2-4 hours after PCI
    Circa 2-4 ore dopo la procedura
    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 No
    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.8.5.1Number 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 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 years1
    E.8.9.1In the Member State concerned months0
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 2021-10-01. Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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)
    None
    Nessuno
    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 Decision2015-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-23
    P. End of Trial
    P.End of Trial StatusOngoing
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