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    Summary
    EudraCT Number:2013-000631-27
    Sponsor's Protocol Code Number:NCT01778842
    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:2013-05-23
    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 number2013-000631-27
    A.3Full title of the trial
    PhaRmacodynamic Effect of antiplatelet agents in elderly patients: Standard clopidogrel versus prasugrEl low dose Therapy.
    Effetto farmacodinamico degli antiaggreganti nei pazienti anziani: terapia standard con clopidogrel versus bassa dose di prasugrel
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison between standard clopidogrel therapy and low dose of prasugrel in elderly patients.
    Paragone tra la terapia con dose standard di clopidogrel e la bassa dose di prasugrel.
    A.4.1Sponsor's protocol code numberNCT01778842
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01778842
    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 UNIVERSITARIA POLICLINICO UMBERTO I 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 supportAZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    B.5.2Functional name of contact pointEmodinamica A
    B.5.3 Address:
    B.5.3.1Street AddressVia del Policlinico 155
    B.5.3.2Town/ cityRome
    B.5.3.3Post code00161
    B.5.3.4CountryItaly
    B.5.4Telephone number00390649979046
    B.5.5Fax number00390649979047
    B.5.6E-mailcalcagnosimone@libero.it
    D. IMP Identification
    D.IMP: 1
    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 holderTEVA PHARMA
    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 namePLAVIX
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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.3.9.1CAS number 94188-84-8
    D.3.9.3Other descriptive nameCLOPIDOGREL
    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 Yes
    D.3.11.13.1Other medicinal product typeANTIARITMICO
    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 Yes
    D.2.1.1.1Trade name EFIENT
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY
    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 IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPRASUGREL
    D.3.9.1CAS number 150322-43-3
    D.3.9.3Other descriptive namePRASUGREL
    D.3.9.4EV Substance CodeSUB30236
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeANTIAGGREGANTI
    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 over 75 years with acute coronary syndrome
    Pazienti over 75 con sindrome coronarica acuta
    E.1.1.1Medical condition in easily understood language
    Patients over 75 with acute myocardial infarction and unstable angina
    Pazienti over 75 con infarto miocardico acuto e con 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 16.1
    E.1.2Level PT
    E.1.2Classification code 10051592
    E.1.2Term Acute coronary syndrome
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10071111
    E.1.2Term Non ST segment elevation 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
    The primary aim will be to investigate the antiplatelet effect of half dose of prasugrel (5 mg) versus standard dose of clopidogrel in patients with acute coronary syndrome and coronary diseases, treated with percutaneous coronary intervention and stent implantation.
    Lo scopo dello studio è quello di confrontare gli effetti farmacodinamici della standard dose di clopidogrel vs la dose ridotta di prasugrel in pazienti con sindrome coronarica acuta e responder alla terapia standard con clopidogrel
    E.2.2Secondary objectives of the trial
    We will assess the different variability in terms of therapeutic window maintenance between the two drugs. Bleeding (major, minor, or minimal according to the TIMI study criteria) and major adverse cardiac events (cardiovascular death, myocardial infarction, and stroke) will be evaluated during the all period of treatment.
    Abbiamo intenzione di controllare la variabilità in termini di mantenimento della finestra terapeutica tra i due farmaci. I sangiunamenti (criterio TIMI) e gli eventi avversi cardiaci maggiori (morte cardiovascolare, infarto miocardico e stroke) saranno valutati durante tutto il periodo di trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pazients over 75 years with acute coronary syndrome (unstable angina, NSTEMI and STEMI) undergoing percutanous coronary angioplasty and responder to clopidogrel therapy.
    Pazienti con più di 75 anni e con sindrome coronarica acuta (angina instabile, infarto STEMI e NSTEMI) sottoposti ad impianto di stent coronarico e risultanti responder alla terapia con clopidogrel.
    E.4Principal exclusion criteria
    Pazients under 75 year and patients without acute coronary syndrome
    Pazienti con meno di 75 anni e che non presentano una sindrome coronarica acuta
    E.5 End points
    E.5.1Primary end point(s)
    The primary end-point of the study is to demonstrate the superiority antiplatelet effect of half dose of prasugrel compared to standard dose of clopidogrel into therapeutic window, at the study periods.
    L'end point primario dello studio è di dimostrare la superiorità di effetto della mezza dose di prasugrel paragonata al clopidogrel nella finestra terapeutica durante il periodo dello studio
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoint of evaluation of this study is 1 month.
    L'end point primario verrà valutato dopo un mese.
    E.5.2Secondary end point(s)
    Secondary end-points included the rate MACCE (major adverse cerebro-cardiovascular events, i.e. the composite of death, myocardial infarction [defined according to the Academic Research Consortium statement],(17) target vessel revascularization or stroke), major bleedings (Bleeding Academic Consortium [BARC] 3-5),(18) minor bleeding (BARC 2), and NACE (net adverse clinical events, i.e. the composite of MACCE and major bleedings) up to 12 months
    L'end point secondario include la percentuale di MACCE (morte, infarto miocardico, rivascolarizzazione del vaso target) sanguinamenti maggiori, sanguinamenti minori e NACE (insieme di MACCE e sanguinamenti maggiori) ad un anno.
    E.5.2.1Timepoint(s) of evaluation of this end point
    telephone-based interviews and office-based direct visits will be performed at 7-14-21 and 28 days and 12 months, respectively, for end-point adjudication.
    Telefonate di intervista e visite dirette saranno effettuate a 7-14-21 e 28 giorni e a 12 mesi per la verifica degli end points.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) 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 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.8.5The 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
    1 year 6 months
    1 anno 6 mesi
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years14
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days2
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 No
    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 state68
    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
    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 Decision2014-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-13
    P. End of Trial
    P.End of Trial StatusOngoing
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