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    Summary
    EudraCT Number:2017-002419-32
    Sponsor's Protocol Code Number:2017-40
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-08-29
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-002419-32
    A.3Full title of the trial
    COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with STEMI undergoing primary percutaneous coronary interventions’
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COMPARison of pre-hospital CRUSHed vs. uncrushed Prasugrel tablets in patients with acute heart infarct undergoing dotter treatment.
    A.3.2Name or abbreviated title of the trial where available
    Compare Crush
    A.4.1Sponsor's protocol code number2017-40
    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 SponsorResearch Maatschap Cardiologen Rijnmond Zuid
    B.1.3.4CountryNetherlands
    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 supportDaiichi Pharmaceutical
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportMicroport
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationResearch Maatschap Cardiologen Rijnmond Zuid
    B.5.2Functional name of contact pointRia van Vliet - project manager
    B.5.3 Address:
    B.5.3.1Street AddressMaasstadweg 21
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3079 DZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31102913278
    B.5.5Fax number31102913065
    B.5.6E-mailVlietM@maasstadziekenhuis.nl
    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 Efient
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.2Product code B01AC22
    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 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 Efient
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.2Product code B01AC22
    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 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
    ST elevated Myocardial infarction (STEMI)
    E.1.1.1Medical condition in easily understood language
    Acute heart infarct
    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 LLT
    E.1.2Classification code 10064346
    E.1.2Term STEMI
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of crushed vs. integral tablets of prasugrel loading dose treatment by comparing the percentage of patients reaching the co-primary endpoint of TIMI flow grade 3 of MI culprit vessel at initial angiography or a ≥70% ST-segment elevation resolution 60min post-PCI.
    E.2.2Secondary objectives of the trial
    - level of platelet inhibition at first medical contact, beginning and end of PCI procedure, as well as at 4 hours after prasugrel administration
    - platelet reactivity, at each time point as well as over time
    - rates of HPR
    - exploratory analyses within each group to evaluate any differences in PD among patients receiving morphine
    - Time –relationship (from symptom onset to 1st dose intake) on each primary
    - Time –relationship (from 1st dose intake to/ angiography and to ECG 1h after PCI) on each primary
    - ≥70% ST-segment resolution pre-PCI and directly after PCI
    - Corrected TIMI frame count (cTFC) at angiography, pre and post PCI
    - TIMI myocardial perfusion grade (TMPG) at angiography, pre and post PCI
    - TIMI myocardial blush grade at angiography, pre and post PCI
    - TIMI flow grade 3 at end of procedure
    - Composite of death, MI, stroke, urgent revascularization and acute stent thrombosis in-hospital, during 30 days and 12 months of treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Consecutive patients with STEMI planned for primary PCI:

    - Deferred written informed consent within 4 hours after prasugrel loading dose
    - Adult men and women aged at least 18 years
    - Symptoms of acute MI of more than 30 min but less than 6 hours
    - New persistent ST-segment elevation ≥ 1 mm in two or more contiguous ECG leads
    E.4Principal exclusion criteria
    - Contraindication to prasugrel (e.g., hypersensitivity, active bleeding, history of previous intracranial bleed, history of any CVA including TIA, moderate to severe hepatic impairment, GI bleed within the past 6 months, major surgery within past 4 weeks)
    - Patient who has received loading dose of clopidogrel or ticagrelor for the index event or are on chronic treatment of ticagrelor, or prasugrel. Patients on maintenance dose clopidogrel for at least 7 days are included.
    - Oral anticoagulation therapy that cannot be stopped (i.e. patients requiring chronic therapy)
    - Planned fibrinolytic treatment
    - Patient requiring dialysis
    - Known, clinically important thrombocytopenia
    - Known clinically important anaemia
    - Known pregnancy or lactation
    - Need for a concomitant systemic therapy with strong inhibitors or strong inducers of CYP3A
    - Condition which may either put the patient at risk or influence the result of the study (e.g., cardiogenic shock with severe hemodynamic instability, active cancer, risk for non-compliance, risk for being lost to follow up)
    - Patient unable to swallow oral medication (i.e. intubated patients)
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary endpoint is the percentage of patients reaching TIMI flow grade 3 of MI culprit vessel at initial angiography or a ≥70% ST-segment resolution 60min post-PCI
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 minutes post-PCI
    E.5.2Secondary end point(s)
    Percentage of patients in the following: composite of death, MI, stroke, urgent revascularization and acute stent thrombosis during inhospital stay, 30 days and 12 months of study
    Percentage of patients in the following: composite of death, MI, or urgent revascularization during inhospital, 30 days and 12 months of study
    Percentage of patients presenting with any of the individual endpoints during inhospital, 30 days and 12 months of study
    Percentage of patients receiving thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI
    Complete (≥ 70%) ST-segment elevation resolution pre -PCI and directly post-PCI
    Corrected TIMI frame count (cTFC) at angiography, pre and post PCI
    TIMI myocardial perfusion grade (TMPG) at angiography, pre and post PCI
    Time from symptom onset to 1st dose intake correlated to TIMI flow grade 3 of MI culprit vessel at initial angiography and on ≥70% ST-segment elevation resolution 60min post-PCI
    Time from first dose intake to ECG correlated to ≥70% ST-segment elevation resolution 60min post-PCI and time from randomization to initial angiography correlated to TIMI flow grade 3 of MI culprit vessel
    TIMI flow grade 3 at end of procedure
    Myocardial blush at the start and end of the procedure
    Maximum CK, and CK-MB levels
    PRU measurements at first medical contact, beginning and end of PCI, as well as 4 after drug administration
    PRU measurements at first medical contact, beginning and end of PCI, as well as 4hours after drug administration
    Percentage of patients with PRU values over HPR threshold
    PRU of each group among patients stratified for morphine treatment
    Percentage of patients having a bleeding event defined by the TRITON TIMI-38 and BARC bleeding definitions, within the first 48 hours, (i.e. primary safety endpoint) during 30 days and 12 months of study
    Interaction analysis on primary and secondary endpoints depending on stratified randomization group (clopidogrel naïve vs. clopidogrel MD)
    A secondary efficacy analysis will be performed in:
    a) all randomized patients
    b) all STEMI patients who underwent primary PCI
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2.
    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 No
    E.6.4Safety No
    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 No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    comperator will Efient as integral tablets,study medication will be Efient as crushed tablets.
    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 concerned2
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months42
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months42
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 374
    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 2017-08-29. 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 state674
    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 Decision2017-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-15
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