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    Summary
    EudraCT Number:2012-001522-10
    Sponsor's Protocol Code Number:SWITCH
    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:2012-04-02
    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 number2012-001522-10
    A.3Full title of the trial
    SWITCH STUDY
    STUDIO SWITCH
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ASSESSING THE EFFECTS OF SWITCHING THERAPY FROM CLOPIDOGREL TO PRASUGREL IN PATIENTS WITH ACUTE CORONARY SYNDROME ALREADY TREATED WITH CLOPIDOGREL
    VALUTARE GLI EFFETTI DEL CAMBIO DI TERAPIA DA CLOPIDOGREL A PRASUGREL NEI PAZIENTI CON SINDORME CORONARICA ACUTA CHE GIA' EFFETTUAVANO LA TERAPIA CON CLOPIDOGREL
    A.3.2Name or abbreviated title of the trial where available
    SWITCH
    SWITCH
    A.4.1Sponsor's protocol code numberSWITCH
    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 organisationPOLICLINICO UNIVERSITARIO 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 number06225411
    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 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 INNPRASUGREL HYDROCHLORIDE
    D.3.9.1CAS number 389574-19-0
    D.3.9.4EV Substance CodeSUB30234
    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.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
    NSTE-ACS undergoing coronary angioplasty, already treated with clopidogrel in combination with aspirin at the time of the procedure
    ACS-NSTE sottoposti ad angioplastica coronarica, già in terapia con Clopidogrel in associazione ad aspirina al momento della procedura
    E.1.1.1Medical condition in easily understood language
    PATIENTS WITH UNSTABLE ANGINA OR MYOCARDIAL INFARCTION undergoing to angioplasty and already treated with CLOPIDOGREL
    PAZIENTI CON ANGINA INSTABILE O INFARTO MIOCARDICO DA SOTTOPORRE AD ANGIOPLASTICA E IN TRATTAMENTO CON CLOPIDOGREL
    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
    The aim of the study SWITCH is therefore to assess whether in patients with ACS without ST elevation, already treated with clopidogrel and undergoing stent implantation, a switch to prasugrel therapy might provide more protection from ischemic complications / thrombotic cardiac compared to standard therapy with clopidogrel.
    Scopo dello studio SWITCH è quindi quello di valutare se in pazienti con ACS senza sopraslivellamento del tratto ST, già in terapia con clopidogrel e sottoposti ad impianto di stent, uno switch terapeutico verso il prasugrel possa conferire una protezione maggiore dalle complicanze ischemiche/trombotiche cardiache rispetto ad una terapia standard con clopidogrel.
    E.2.2Secondary objectives of the trial
    nd
    nd
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Unstable angina or non ST-elevation myocardial infarction undergoing coronary angioplasty, already treated with clopidogrel in combination with aspirin at the time of the procedure (chronic therapy with 75 mg / day for at least 5 days, 300 mg loading at least 12 hours, load of 600 mg of at least 6 hours).
    Angina instabile o infarto miocardico senza sovraslivellamento del tratto ST sottoposti ad angioplastica coronarica, già in terapia con Clopidogrel in associazione ad aspirina al momento della procedura (terapia cronica con 75 mg/die da almeno 5 giorni, carico di 300 mg da almeno 12 ore, carico di 600 mg da almeno 6 ore).
    E.4Principal exclusion criteria
    1. Patients undergoing primary coronary angioplasty for myocardial infarction with ST-segment sovraslivellamento
    2. Patients older than 75 years
    3. Patients weighing less than 60 kg
    4. Patients with a recent episode of major bleeding (<6 months)
    5. Patients with platelet counts below 70 × 10 * 9 / L
    6. Patients with recent or past history of stroke or transient ischemic attack
    7. Patients with cardiac surgery or in the previous three months
    8. Patients with anemia
    1. Pazienti da sottoporre ad angioplastica coronarica primaria per infarto miocardico con sovraslivellamento del tratto ST
    2. Pazienti con età superiore a 75 anni4
    3. Pazienti con peso corporeo inferiore a 60 kg4
    4. Pazienti con recente episodio di sanguinamento maggiore (&lt; 6 mesi)
    5. Pazienti con conta piastrinica inferiore a 70 × 109/L
    6. Pazienti con recente o pregressa storia di stroke o attacco ischemico transitorio cerebrale
    7. Pazienti con intervento chirurgico o cardiochirurgico nei precedenti tre mesi
    8. Pazienti con anemia
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of major adverse cardiac events 30 days after procedure
    Incidenza a 30 giorni dall’angioplastica coronarica di eventi cardiaci avversi maggiori
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days
    30 giorni
    E.5.2Secondary end point(s)
    1. Evaluation of peri-procedural residual platelet reactivity.
    2. Incidence of stent thrombosis at 30-days follow-up
    3. Incidence of bleeding complications according to the criteria TIMI (major bleeding: intracranial hemorrhage, or associated with a decrease in hemoglobin of 5 g / dL; minor bleeding: reduction of hemoglobin <5 g / dl) or access site complications (hematoma more of 10 cm, or femoral artery pseudoaneurysm arteriovenous fistulas).
    4. Evaluation of the expression of micro-RNA pre-and post-procedure in the four treatment arms.
    1. Valutazione peri-procedurale della reattività piastrinica residua.
    2. Incidenza di trombosi intra-stent a 30 giorni di follow-up.
    3. Incidenza di complicanze emorragiche secondo i criteri TIMI7 (emorragie maggiori: emorragie intracraniche o associate ad una diminuzione di emoglobina di 5 g/dL; emorragie minori: riduzione di emoglobina <5 g/dl) o di complicanze del sito d’accesso (ematomi maggiori di 10 cm, pseudoaneurismi dell’arteria femorale o fistole artero-venose).
    4. Valutazione dell’espressione dei micro-RNA pre e post-procedura nei quattro bracci di trattamento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days
    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) 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 Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial4
    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.8.6 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 months12
    E.8.9.1In the Member State concerned 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 2012-04-02. 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 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 state80
    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)
    NORMAL CLINICAL PRACTICE
    NORMALE PRASSI CLINICA
    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 Decision2012-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-27
    P. End of Trial
    P.End of Trial StatusOngoing
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