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    Summary
    EudraCT Number:2013-002670-40
    Sponsor's Protocol Code Number:NL44913.029.13
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-09-20
    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 number2013-002670-40
    A.3Full title of the trial
    Noninvasive Imaging of Vulnerable Inflammatory Coronary Plaque using Cardiac PET/CT in Humans: a feasibility study
    Onderzoek naar het gebruik van verschillende PET-tracers voor het vaststellen van instabiele vernauwingen in de coronairarterieen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of PET tracers for their ability to determine coronary stenosis at risk for rupture.
    A.3.2Name or abbreviated title of the trial where available
    VIP
    VIP
    A.4.1Sponsor's protocol code numberNL44913.029.13
    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 SponsorVU University Medical Center (VUmc)
    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 supportVU University Medical Center (VUmc)
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical Center (VUmc)
    B.5.2Functional name of contact pointclinicaltrials.gov
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.6E-mailw.stuijfzand@vumc.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 No
    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 name[11C]PK11195
    D.3.2Product code 1600.XXXX
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN[11C]PK11195
    D.3.9.3Other descriptive name[11C]PK11195
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 2000
    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 Yes
    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
    The IMP (PET-tracer) will be investigated in patients 24-72 hours after an acute coronary syndrome without excessive enzyme release (CK < 180 U/L) during PET scanning protocol.
    Het onderzoeksproduct (PET-tracer) wordt onderzocht tijdens een PET-scan bij patienten 24-72 uur na een acuut coronair syndroom zonder significant enzymestijging (CK < 180 U/L).
    E.1.1.1Medical condition in easily understood language
    The PET-tracer (IMP) will be investigated in patients with a small heart infarct (CK < 180 U/L) or unstable angina. A PET-scan will be performed with administration of the investigational tracer.
    De PET-tracer zal worden onderzocht bij patienten met een klein hartinfarct (CK < 180 U/L) of instabiele angina pectoris tijdens een PET-scan
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10066521
    E.1.2Term Coronary artery disease progression
    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
    The objective is to study the feasibility of different PET tracers to detect vulnerable plaques in patients with a recent acute coronary syndrome and co-localize these inflammatory lesions with anatomical plaque features obtained with CT based coronary angiography (CCTA).
    Het doel van de studie is vast te stellen of verchillende PET-tracers de infectieuze eigenschappen van instabiele coronaire vernauwingen aan kan tonen bij patienten met een recent acuur coronair syndroom
    E.2.2Secondary objectives of the trial
    Pharmacokinetics of the PET-tracers
    Farmacokinetiek van de PET-tracers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with an acute coronary syndrome and accompanying ECG abnormalities (unstable angina / non-ST-elevation myocardial infarction without significant enzyme release (CK < 180 U/L).
    • Clinical indication for invasive coronary angiography within 72 hours upon admission based on ESC guidelines pertaining treatment of patients with unstable angina or non-ST segment elevation myocardial infarction.
    • Age 35-65 years
    • Patienten met een acuut coronair syndroom met gepaardgaande ECG-afwijkingen (instabiele angina pectoris / Myocardinfarct zonder ST-elevatiezonder significantw enzymestijging (CK < 180 U/L).
    • Klinische indicatie voor coronair angiografie binnen 72 uur gebasseerd op ESC guidelines
    • Leeftijd 35-65 jaar
    E.4Principal exclusion criteria
    • Prior cardiac history (e.g. percutaneous coronary intervention, coronary artery bypass surgery, or myocardial infarction)
    • History of systemic inflammatory disease
    • Cardiac arrhythmia
    • Prior medication use (e.g. statins or anti-inflammatory agents)
    • Renal failure (estimated glomerular filtration rate < 60 ml/min)
    • Refusal or inability to give informed consent
    • Cardiale voorgeschiedenis gedefineerd als: PCI, CABG of myocardinfarct
    • Voorgeschiedenis met een systemische inflammatoire ziekte
    • A-ritmie
    • Gebruik van anti-inflammatoire medicatie of statine
    • Nierfunctiestoornissen (eGFR < 60 ml/min)
    • Geen informed consent
    E.5 End points
    E.5.1Primary end point(s)
    This feasibility study will test different tracers for their feasibility to detect culprit lesions of patients with an ACS. Endpoints will be sufficient target to background uptake of tracer beyond 1.2 that coincides with the culprit lesion identified with OCT
    Deze studie zal verschillende tracers op hun potentie en mogelijkheid testen om laesies van patiënten te detecteren met een ACS. Het eindpunt is het aantonen van de instabiele plaque met een experimentele tracer met een opname-achtergrond ratio van 1.2 of groter.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On per patient basis evaluation will be reached within one week. On per study basis inclusion will be performed within one year, thereby endpoint will be reached.
    Per patient zal het eindpunt binnen een week geevalueerd worden. De inclusie van de studie zal plaatsvinden binnen een jaar tijd. Dan zal het eindpunt geanalyseerd over alle patienten bekend zijn.
    E.5.2Secondary end point(s)
    Pharmacokinetics
    farmacokinetiek
    E.5.2.1Timepoint(s) of evaluation of this end point
    Conform primary endpoint
    Conform primaire eindpunt
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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 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
    The study will be ended when the last patient (no.24) is included and underwent PET-scan and invasive coronary angiography.
    The studie zal worden beeindigd wanneer de laast geincludeerde patient (nr 24) de PET-scan en hartkatheterisatie heeft ondergaan.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    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.1.1.1In 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: 24
    F.1.3Elderly (>=65 years) No
    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 state24
    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)
    Regular care depending on clinical outcome of invasive coronary angiography. This study will not interfere regular secific care.
    De reguliere patient specifieke behandeling blijft van toepassing, zowel tijdens als na het onderzoek.
    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 Decision2015-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-11-15
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