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    Summary
    EudraCT Number:2011-004265-32
    Sponsor's Protocol Code Number:0206
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-11-23
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-004265-32
    A.3Full title of the trial
    Left Ventricular Thrombus Formation after Acute Myocardial Infarction - a randomized multi-center trial comparing 2 different anti-thrombotic regimens
    Linker Ventrikel Thrombus Formatie na het Acuut Myocardinfarct - een gerandomiseerde multi-center onderzoek die 2 verschillende anti-trombotische strategien vergelijkt
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Thrombus formation in the left chamber of the heart after an acute heart infarction
    Stolsel in de linker kamer van het hart na een acuut hartinfarct
    A.3.2Name or abbreviated title of the trial where available
    LV thrombus after AMI
    LV thrombus na AMI
    A.4.1Sponsor's protocol code number0206
    A.5.4Other Identifiers
    Name:LV thrombus studyNumber:LV thrombus study
    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 SponsorAcademic Medical Center
    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 supportDutch Heart foundation
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointstudy-coordinator
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205666405
    B.5.5Fax number0031206962609
    B.5.6E-mailr.delewi@amc.uva.nl
    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 acenocoumarol
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz BV.
    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 nameAcenocoumarol
    D.3.2Product code RVG 50674
    D.3.4Pharmaceutical form Oral drops
    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 INNACENOCOUMAROL
    D.3.9.1CAS number 152-72-7
    D.3.9.3Other descriptive nameLV thrombus study
    D.3.9.4EV Substance CodeSUB05211MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2 to 3
    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
    Left Ventricular thrombus formation after acute myocardial infarction
    Linker kamer thrombus na het acuut myocardinfarct
    E.1.1.1Medical condition in easily understood language
    Thrombus in the left chamber of the heart after an acute heart infarction
    Stolsel in de linker kamer van het hart na een acuut hartinfarct
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10053755
    E.1.2Term Vitamin K antagonist
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to determine in a randomized fashion the risks as well as the benefits of the addition of vitamin K antagonists to dual anti-platelet therapy in patients with primary PCI-treated AMI and LV thrombus formation.
    E.2.2Secondary objectives of the trial
    For the first time patients will be evaluated post-MI simultaneously with both cardiovascular as well as cerebral MRI. Patients with LV thrombus will be screened specifically for the occurrence of cerebral micro-embolization. Micro-embolization is a potential late complication of acute MI and post-infarct pharmacological therapy in patients with LV thrombus should aim at the prevention of both major thrombo-embolic events as well as silent ischemic stroke.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Suspected LV thrombus on echocardiography or routine MRI
    2.Ongoing treatment with dual antiplatelet therapy (e.g. ASA and clopidogrel) at the time of
    randomization
    1. Verdachte LV thrombus op echocardiografie of MRI
    2. Huidige behandeling met duale antiplaatjes therapue (bijvoorbeeld aspirine en clopidogrel)
    E.4Principal exclusion criteria
    The following exclusion criteria are applied:
    1 Younger than 18
    2 Clinically or hemodynamically unstable
    3 Treatment with vitamin K antagonist prior to PCI or other expected indication for vitamin K antagonist treatment (e.g. atrium fibrillation) within the next 6 months
    4 Previous stroke or transient ischemic attack
    5 Scheduled for major surgery (including CABG) during the course of the study
    6 Active bleeding or high risk for bleeding contraindicating treatment with vitamin K antagonists
    7 Contra-indication for vitamin K treatment
    8 Chronic treatment with NSAIDs or COX-2 inhibitors for more than 4 days per week anticipated to continue during the study
    9 Congenital cardiac disease
    10 Presence of supraventricular or ventricular arrhythmias
    11 Expected candidate for ICD implantation with the next 6 months
    12 Severe renal impairment (estimated CrCl calculated by Cockcroft-Gault equation
    ≤ 30mL/min)
    13 Known or symptomatic brain disease (e.g. brain tumor)
    14 Women who are pregnant.

    15 Any contraindication for Contrast-Enhanced Magnetic Resonance Imaging i.e.:
    • pacemaker
    • cerebrovascular clips
    • known contrast allergy
    • claustrophobia
    16 Follow-up impossible (no fixed abode, etc)
    Leeftijd lager dan 18 jaar.
    2 Klinisch of hemodaynamisch instabiel
    3 Behandeling met vitamine K antaginist voor de dotterprocedure of een verwachte
    indicatie met vitamine K antagonist (bijv. atrium fibrilleren) in de komende 6 maanden
    4 Herseninfarct of Transient Ischemic Attack in de voorgeschiedenis
    5 Ingepland voor grote chirurgie (inclusief CABG) gedurende de looptijd van de
    studie
    6 Geschiedenis van intracraniale, intraoculaire, spinale, retroperitoneale or
    atraumatische intra-articulaire bloedingen, tenzij de oorzakelijk factor permanent is
    weggenomen (bijvoorbeeld door chirugie)
    7 Verhoogde bloedingsneigingen of stollingsziekten
    8 Congentiale hartaandoeningen
    9 Aanwezigheid van supraventriculaire or ventriculaire arritmieen
    10 Verwachte kandidaat voor ICD implantatie in de komende 6 maanden
    11 Ernstige nieraandoening (geschatte CrCl berekend met de Cockcroft-Gault equation
    ≤ 30mL/min)
    12 Bekende of symptomatische hersentumor
    13 Contra-indicatie voor Magnetic Resonance Imaging bijvoorbeeld.:
    • pacemaker
    • cerebrovasculiare clips
    • claustrofobie
    14 Geen mogelijkheid tot follow-up (geen vaste verblijfplaats, etc)
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is defined as presence of new cerebral (micro-) infarcts at 6 months relative to baseline measured by MRI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    1. composite of vascular death, recurrent myocardial infarction, stroke or systemic embolism
    2. occurrence of major and minor bleeding
    3. presence of new cerebral mirco-bleeds
    4. neurological status
    5. quality of life.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6, 12 months and 5 year
    6, 12 maanden en 5 jaar
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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 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
    6 months end of study medication
    6 maanden einde van de studie medicatie
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 150
    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 No
    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 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 state250
    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)
    patients are referred to their own cardiologists for treatment
    patienten worden terug verwezen naar hun eigen cardioloog voor verdere behandeling
    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 Decision2012-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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