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    Summary
    EudraCT Number:2012-003423-37
    Sponsor's Protocol Code Number:PRIME
    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:2012-08-02
    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 number2012-003423-37
    A.3Full title of the trial
    Prospective randomized study ARMYDA PRIME
    Studio prospettico randomizzato ARMYDA PRIME
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective randomized study on antiplatelet treatment in patients with acute myocardial infarction with ST elevation
    Studio prospettico randomizzato sul trattamento antiaggregante in pazienti con infarto miocardico acuto con sopraslivellamento del tratto ST
    A.4.1Sponsor's protocol code numberPRIME
    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 SponsorUNIVERSITA' CAMPUS BIOMEDICO
    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 supportUNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNIVERSITA' CAMPUS BIO-MEDICO DI ROMA
    B.5.2Functional name of contact pointCARDIOLOGIA
    B.5.3 Address:
    B.5.3.1Street AddressVIA ALVARO DEL PORTILLO 200
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00128
    B.5.3.4CountryItaly
    B.5.4Telephone number06225411143
    B.5.5Fax number06225411638
    B.5.6E-mailg.patti@unicampus.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 EFIENT*28CPR RIV 10MG
    D.2.1.1.2Name of the Marketing Authorisation holderDAIICHI SANKYO ITALIA 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 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 150322-43-3
    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 No
    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 BRILIQUE*56CPR 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 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 274693-27-5
    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 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
    patients with acute myocardial infarction with ST elevation (STEMI)
    pazienti con infarto miocardico acuto con sopraslivellamento del tratto ST (STEMI)
    E.1.1.1Medical condition in easily understood language
    INFARCTION WITH CARDIAC MUSCLE NECROSIS AND SIGNIFICANT INCREASE OF CARDIAC ENZYMES
    INFARTO CHE PRESENTA NECROSI DEL MUSCOLO CARDIACO CON SIGNIFICATIVO RIALZO DEGLI ENZIMIO CARDIACI
    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 SOC
    E.1.2Classification code 10007541
    E.1.2Term Cardiac disorders
    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
    COMPARING THE EFFICACY AND SAFETY ticagrelor AGAINST prasugrel in STEMI
    CONFRONTARE L'EFFICACIA E LA SICUREZZA DEL PRASUGREL CONTRO TICAGRELOR NEI PAZIENTI CON STEMI
    E.2.2Secondary objectives of the trial
    ASSESSING THE IMPACT OF A CLINICAL 30 DAYS
    VALUTARE L'IMPATTO CLINICO A 30 GIORNI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    patients with STEMI who are candidates for early invasive strategy
    pazienti con STEMI candidabili a strategia invasiva precoce
    E.4Principal exclusion criteria
    1. Patients over 75 years of age
    2. Patients weighing under 65 kg
    3. Patients with previous cerebrovascular events
    4. Patients with platelet counts below 70 × 109 / L
    5. Patients undergoing surgery for aorto-coronary bypass in the previous three months
    6. Patients with a recent episode of major bleeding (<6 months)
    1. Pazienti di etá superiore ai 75 anni
    2. Pazienti con peso corporeo inferiore ai 65 kg
    3. Pazienti con pregressi eventi cerebrovascolari
    4. Pazienti con conta piastrinica inferiore a 70 × 109/L
    5. Pazienti sottoposti ad intervento di by-pass aorto-coronarico nei precedenti tre mesi
    6. Pazienti con recente episodio di sanguinamento maggiore (&lt; 6 mesi)
    E.5 End points
    E.5.1Primary end point(s)
    evaluating the extent of infarction, defined as the area under the curve of CK-MB and troponin-I, calculated by linear trapezoidal method
    valutazione dell’estensione dell’infarto, definita come area sotto la curva di CK-MB e troponina-I, calcolata con metodo lineare trapezoidale
    E.5.1.1Timepoint(s) of evaluation of this end point
    BEFORE PCI, 4, 8,12,24, 36, 48 and 72 hours after PCI
    PRIMA DELL'ANGIOPLATICA, 4, 8,12,24, 36, 48 E 72 ORE DOPO L'ANGIOPLASTICA
    E.5.2Secondary end point(s)
    1. Prevalence of coronary TIMI flow grade> 1 prior to PCI and <3 after PCI 2. Left ventricular ejection fraction assessed by echocardiography pre-discharge
    3. Incidence of major cardiovascular events at 30 days
    4. Incidence of bleeding events / complications of the access site at 30 days
    1. Prevalenza di flusso coronarico TIMI di grado >1 prima dell’angioplastica e <3 dopo l’angioplastica
    2. Frazione d’eiezione del ventricolo sinistro valutata all’ecocardiogramma pre-dimissione
    3. Incidenza di eventi cardiovascolari maggiori a 30 giorni
    4. Incidenza di eventi emorragici / complicanze del sito d’accesso a 30 giorni
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. BEFORE AND AFTER PCI
    2. PRE DISCHARGE
    3. 30 DAYS
    4. 30 DAYS
    1. PRIMA E DOPO PCI
    2. PRE DIMISSIONE
    3. 30 GIORNI
    4. 30 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) 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 years0
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months13
    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.1.1Number 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 2012-08-02. 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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    CONTINUE THE STANDARD MEDICAL THERAPY IN AGREEMENT WITH THE GUIDELINES
    CONTINUA LA TERAPIA MEDICA STANDARD IN ACCORDO CON LE LINEE GUIDA
    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 Decision2012-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-31
    P. End of Trial
    P.End of Trial StatusOngoing
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