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    Summary
    EudraCT Number:2017-001834-25
    Sponsor's Protocol Code Number:MasterDapt
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-05-07
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-001834-25
    A.3Full title of the trial
    MAnagement of high bleeding risk patients post bioresorbable polymer coated STEnt implantation with an abbReviated versus prolonged DAPT regimen – MASTER DAPT
    Management von Patienten mit hohem Blutungsrisiko nach Implantation von Stents aus bioresorbierbarem Polymer mit einem zeitlich verkürzten gegenüber einem zeitlich verlängerten DAPT-Behandlungsschema – MASTER DAPT
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To compare two medication therapies to prevent thrombus (blood cloth) formation following the successful treatment of a coronary heart disease with expansion of coronary stent (metallic tube) covered with medication (Drug Eluting Stent-DES): a shortened versus a prolonged dual antiplatelet therapy (DAPT, drugs that inhibit bloodplatelets, blood cells involved in the thrombus formation process).
    Das Ziel dieser Studie ist, zwei medikamentöse Therapien zur Prävention von Thrombenbildung (Blutgerinnsel) miteinander zu vergleichen, nach erfolgreicher Behandlung einer koronaren Herzkrankheit mittels eines Medikament-freisetzenden Stents (Drug Eluting Stent, DES). Verglichen wird dabei eine zeitlich verkürzte mit einer zeitlich verlängerten dualen Antiplättchentherapie (DAPT, medikamentöse die Bluttplättchen hemmen, d.h Blutzellen die an der Bildung von Thrombosen beteiligt sind)
    A.3.2Name or abbreviated title of the trial where available
    MASTER DAPT
    MASTER DAPT
    A.4.1Sponsor's protocol code numberMasterDapt
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03023020
    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 SponsorECRI-9
    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 supportTerumo Europe NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationECRI-9
    B.5.2Functional name of contact pointManaging Director
    B.5.3 Address:
    B.5.3.1Street AddressWestblaak 98
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3012 KM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031102062828
    B.5.5Fax number0031102062844
    B.5.6E-mailinfo@ecri-trials.com
    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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.8INN - Proposed INNCLOPIDOGREL
    D.3.9.1CAS number 113665-84-2
    D.3.9.2Current sponsor codeCLOPIDOGREL
    D.3.9.3Other descriptive nameCLOPIDOGREL
    D.3.9.4EV Substance CodeSUB13395MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.8INN - Proposed INNTICAGRELOR
    D.3.9.1CAS number 274693-27-5
    D.3.9.2Current sponsor codeTICAGRELOR
    D.3.9.3Other descriptive nameTICAGRELOR
    D.3.9.4EV Substance CodeSUB30898
    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.IMP: 3
    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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.8INN - Proposed INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.2Current sponsor codeACETYLSALICYLIC ACID
    D.3.9.3Other descriptive nameASPIRIN
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 4
    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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.8INN - Proposed INNPRASUGREL
    D.3.9.1CAS number 150322-43-3
    D.3.9.2Current sponsor codePRASUGREL
    D.3.9.3Other descriptive namePRASUGREL
    D.3.9.4EV Substance CodeSUB30236
    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
    High bleeding risk population represents a significant proportion of coronary artery disease (CAD) patients undergoing coronary stent implantation. Decisions regarding the duration of dual antiplatelet therapy (DAPT) after stent implantation are difficult, especially after implantation of newer generation drug eluting stents (DES) due to conflicting results from recent trials. High bleeding risk patients either male or female eligible for percutaneous coronary intervention will be included.
    Bei Patienten mit koronarer Krankheit stellt die Gruppe derjenigen mit einem hohen Blutungsrisiko einen Anteil der koronaren Stentimplantationen dar. Aufgrund widersprüchlicher Ergebnisse aus jüngsten Studien ist die Entscheidung bezüglich der Dauer der DAPT im Anschluss an eine Stentimplantation, vor allem nach Implantation von Medikamente-freisetzenden Stents der neueren Generation, schwierig. Patienten mit einem hohen Blutungsrisiko, die ein PCI haben können, werden in die Studie berechtigt
    E.1.1.1Medical condition in easily understood language
    Patients with different levels of chest pain, due to poor blood flow to the heart, and an increased risk for bleeding. A stent is placed to reopen the artery followed by treatment with medicines.
    Patienten mit verschiedenen Schmerzen, wegen des schlechten Blutflusses zum Herzen und ein erhöhtes Blutungsrisiko. Ein Stent wird implantiert um ein verengtes bzw. blockiertes Gefäß wieder zu öffnen
    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 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 objective is to compare, within current guidelines and instructions for use, an abbreviated versus a prolonged DAPT duration after bioresorbable polymer coated Ultimaster sirolimus-eluting stent implantation in patients presenting High Bleeding Risk features.
    Ziel der Studie ist es, eine verkürzte mit einer verlängerten DAPT-Dauer, nach Implantation eines mit einem bioresorbierbaren Polymer beschichteten, Sirolimus-freisetzenden Ultimaster-Stents, bei Patienten, die Merkmale eines HBR aufweisen, im Rahmen aktueller Richtlinien (RL) und Anwendungshinweise (AH) miteinander zu vergleichen.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    After index PCI, patients aged 18 years or more are eligible for inclusion into the study if the following criteria are met:
    1) At least one among the High Bleeding Risk (HBR) criteria (as defined below) is met.
    2) All lesions are successfully treated with Ultimaster stent in the context of routine clinical care, i.e. post-procedural angiographic diameter stenosis <20% by visual estimation
    3) Free from any flow-limiting angiographic complications (i.e. significant untreated dissection or major side-branch occlusion), which require prolonged DAPT duration based on operator’s opinion.
    4) All stages of PCI are complete (if any) and no further PCI is planned.
    Inclusion criteria at one-month randomization visit
    At randomization visit (one month after index PCI), the following criteria must be met:
    1) Fulfilment of at least one HBR criterion (as defined below), or on the basis of post-PCI actionable (i.e. requiring medical attention) non-access site related bleeding episode
    2) Uneventful 30-day clinical course, i.e. free from spontaneous MI, symptomatic restenosis, stent thrombosis, stroke and any revascularization (coronary and non-coronary) requiring prolonged DAPT
    3) If not on OAC,
    a.Patient is on a DAPT regimen of aspirin and a P2Y12 inhibitor
    b.Patient with one type of P2Y12 inhibitor for at least 7 days (i.e. no switching between oral P2Y12 inhibitors has occurred in the previous 7 days)
    4)If on OAC
    a.Patient is on the same type of OAC (e.g. Vitamin K antagonist or NOAC) for at least 7 days
    b.Patient is on clopidogrel for at least 7 days
    Definition of HBR
    Post-PCI patients are at HBR if at least one of the following criteria applies:
    •Clinical indication for treatment with oral anticoagulants (OAC) for at least 12 months
    •Recent (<12 months) non-access site bleeding episode(s), which required medical attention (i.e. actionable bleeding).
    •Previous bleeding episode(s) which required hospitalization if the underlying cause has not been definitively treated (i.e. surgical removal of the bleeding source)
    •Age equal or greater than 75 years
    •Systemic conditions associated with an increased bleeding risk (e.g. haematological disorders, including a history of or current thrombocytopaenia defined as a platelet count <100,000/mm3 (<100 x 109/L), or any known coagulation disorder associated with increased bleeding risk.
    •Documented anaemia defined as repeated haemoglobin levels <11 g/dl or transfusion within 4 weeks before inclusion.
    •Need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs
    •Diagnosed malignancy (other than skin) considered at high bleeding risk including gastro-intestinal, genito-urethral/renal and pulmonary.
    •Stroke at any time or TIA in the previous 6 months
    •PRECISE DAPT score of 25 or greater
    Nach der Index-PCI sind Patienten im Alter von mindestens 18 Jahren zur Aufnahme in die Studie berechtigt, sofern die folgenden Kriterien erfüllt sind.
    1)Es wird mindestens eines der HBR-bezogenen Kriterien (wie unten definiert) erfüllt.
    2)Alle Läsionen wurden im Rahmen einer routinemäßigen klinischen Versorgung erfolgreich mit einem Ultimaster-Stent behandelt, d. h. die postoperative angiographische Durchmesserstenose beträgt nach visueller Einschätzung < 20 %.
    3)Der Patient weist keine den Blutfluss beeinträchtigenden angiographischen Komplikationen (d.h. signifikante unbehandelte Dissektion oder schwerer Seitenastverschluss), die nach Meinung des Chirurgen eine verlängerte Dauer der DAPT erforderlich machen, auf.
    4)Alle Etappen der PCI (falls mehrere) sind abgeschlossen und es ist keine weitere PCI geplant.
    Einschlusskriterien zum 1-Monats Randomisierungsbesuch Zum Randomisierungsbesuch (einen Monat nach der Index-PCI) müssen die folgenden Kriterien erfüllt sein:
    1)Erfüllung von mindestens einem HBR-Kriterium (wie unten definiert) oder auf Grundlage einer post-PCI, handlungserforderlichen (d. h. medizinische Versorgung benötigenden) Blutungsepisode, die nicht mit der Zugangsstelle in Zusammenhang steht
    2)Ereignisfreier 30-tägiger klinischer Verlauf, d. h. kein spontaner Myokardinfarkt, keine symptomatische Restenose, keine Stentthrombose, kein Schlaganfall und keine Revaskularisation (koronar oder nicht-koronar), die eine zeitlich verlängerte DAPT erforderlich machen würde
    3)Falls der Patient nicht mit oralen Antikoagulantien (OAC) behandelt wird:
    a.Patient mit einem Aspirin und P2Y12-Hemmer DAPT-Behandlungsschema
    b.Patient seit mindestens 7 Tagen mit demselben P2Y12-Hemmer (d. h. kein Wechsel von einem oralen P2Y12-Hemmer zu einem anderen in den vorangegangenen 7 Tagen)
    4)Falls der Patient mit oralen Antikoagulantien behandelt wird:
    a.Patient seit mindestens 7 Tagen mit demselben oralen Antikoagulantium (z. B. Vitamin-K-Antagonisten oder NOAK) behandelt
    b.Patient erhält seit mindestens 7 Tagen Clopidogrel
    Definition von HBR
    Bei Patienten besteht ein HBR post-PCI, wenn mindestens eines der folgenden Kriterien erfüllt ist:
    •Klinische Indikation für eine 12-monatige Behandlung mit oralen Antikoagulantien (OAC)
    •Kürzlich erfolgte (< 12 Monate) Blutungsepisode(n) außerhalb der Zugangsstelle, die einer medizinischen Versorgung bedurfte(n) (d. h. eine behandlungsbedürftige Blutung)
    •Vorherige Blutungsepisode(n), die eine Einlieferung ins Krankenhaus erforderlich machte(n), wenn die zugrundeliegende Ursache nicht definitiv behandelt wurde (d. h. chirurgische Entfernung der Blutungsquelle)
    •Der Patient ist 75 Jahre alt oder älter
    •Systemische Erkrankungen, die mit einem erhöhten Blutungsrisiko assoziiert werden (z. B. hämatologische Erkrankungen, einschließlich Anamnese oder aktueller Thrombozytopenie, definiert als Thrombozytenzahl von < 100.000/mm3 (< 100 x 109/l), oder alle bekannten Blutgerinnungsstörungen, die mit einem erhöhten Blutungsrisiko assoziiert wird)
    •Dokumentierte Anämie, definiert als wiederholter Hämoglobinspiegel von < 11 g/dl, oder Transfusion innerhalb der letzten 4 Wochen vor Studieneinschluss
    •Notwendigkeit einer chronischen Behandlung mit Steroiden oder nichtsteroidalen entzündungshemmenden Medikamenten (NSAR)
    •Diagnostizierte Malignität (außer Hautmalignitäten), die mit einem hohen Blutungsrisiko unter anderem für gastrointestinalen, urogenitalen/renalen und pulmonalen assoziiert wird
    •Vorheriger Schlaganfall oder transitorische ischämische Attacke (TIA) innerhalb der vorherigen 6 Monate
    •GENAUER DAPT-Score ist 25 oder darüber
    E.4Principal exclusion criteria
    Patients are not eligible if any of the following applies
    1)Treated with stents other than Ultimaster stent within 6 months prior to index procedure
    2)Treated for in-stent restenosis or stent thrombosis at index PCI or within 6 months before
    3)Treated with a bioresorbable scaffold at any time prior to index procedure
    4)Cannot provide written informed consent
    5)Under judicial protection, tutorship or curatorship
    6)Unable to understand and follow study-related instructions or unable to comply with study protocol
    7)Active bleeding requiring medical attention (BARC≥2) on randomization visit
    8)Life expectancy less than one year
    9)Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor, prasugrel, cobalt chromium or sirolimus
    10)Any planned and anticipated PCI
    11)Participation in another trial
    12)Pregnant or breast feeding women
    Patienten sind nicht teilnahmeberechtigt, wenn eines der folgenden Kriterien zutrifft:
    1)Behandlung mit anderen Stents als Ultimaster-Stents innerhalb von 6 Monaten vor der Indexprozedur
    2)Behandlung einer In-Stent-Restenose oder Stentthrombose während der Index-PCI oder innerhalb von 6 Monaten vor der Index-PCI
    3)Behandlung mit einem bioresorbierbarem Scaffold zu jeglichem Zeitpunkt vor der Indexprozedur
    4)kann keine schriftliche Einverständniserklärung abgeben
    5)steht unter gerichtlichem Schutz bzw. befindet sich unter gerichtlicher Vormundschaft oder Pflegschaft
    6)kann Studienbezogene Anweisungen nicht verstehen und befolgen, oder, das Studienprotokoll nicht einhalten
    7)aktive behandlungsbedürftige Blutung während des Randomisierungsbesuches (BARC > 2)
    8)Lebenserwartung beträgt weniger als 1 Jahr
    9)bekannte Hypersensibilität oder Allergie gegen Aspirin, Clopidogrel, Ticagrelor, Prasugrel, Kobalt-Chrom oder Sirolimus
    10)jegliche geplante oder zu erwartende PCI
    11)Teilnahme an einer anderen klinischen Studie
    12)Schwangere oder stillende Frauen
    E.5 End points
    E.5.1Primary end point(s)
    This study has 3 primary endpoints:
    1)Net adverse clinical endpoints (NACE) defined as a composite of all-cause death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5
    2)Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke
    3)Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events
    The main analyses evaluate the occurrence of the primary endpoints between randomization and 11 months thereafter. In secondary analyses, the occurrence of primary endpoints between randomization and 15 months after index PCI is evaluated.

    Diese Studie besitzt 3 primäre Endpunkte:
    1)Netto unerwünschter klinischer Endpunkte (net adverse clinical endpoints, NACE), zusammengesetzt aus Gesamtmortalität, Myokardinfarkten, Schlaganfällen und Blutungsereignissen, die als BARC 3 oder 5 definiert werden
    2)Schwere unerwünschte kardiale und zerebrale Ereignisse (major adverse cardiac and cerebral events, MACCE) zusammengesetzt aus Gesamtmortalität, Myokardinfarkten und Schlaganfällen
    3)Schwere oder klinisch relevante nicht-schwere Blutungen (major or clinically relevant non-major bleeding, MCB) zusammengesetzt aus Blutungsereignissen des Typs BARC 2, 3 und 5
    Die Hauptanalysen werten das Auftreten der primären Endpunkte zwischen Randomisierung und 11 Monate danach aus. In sekundären Analysen wird das Auftreten der primären Endpunkte zwischen Randomisierung und 15 Monate nach der Index-PCI ausgewertet.
    E.5.1.1Timepoint(s) of evaluation of this end point
    11 months after randomization
    11 Monate nach der Randomisierung
    E.5.2Secondary end point(s)
    The secondary endpoints of the study are the following:
    1)The individual components of each composite primary endpoints
    2)The composite of cardiovascular death, MI, and stroke
    3)The composite of cardiovascular death, MI, and any revascularization
    4)Death from cardiovascular causes
    5)The composite of definite or probable stent thrombosis
    6)Myocardial infarction
    7)Any target vessel revascularization
    8)Urgent target vessel revascularization
    9)Urgent non-target vessel revascularization
    10)Clinically indicated non-target vessel revascularization
    11)Bleeding events according to the BARC, TIMI and GUSTO classification
    12)Transfusion rates both in patients with and/or without clinically detected overt bleeding


    1)Die individuellen Komponenten jedes zusammengesetzten primären Endpunktes
    2)Die Zusammensetzung aus kardiovaskulärem Tod, Herzinfarkten und Schlaganfällen
    3)Die Kombination aus kardiovaskulärem Tod, Myokardinfarkten und Revaskularisationen jeder Art
    4)Tod aufgrund kardiovaskulärer Ursachen
    5)Die Kombination aus definitiver und wahrscheinlicher Stentthrombose
    6)Myokardinfarkt nach der universellen Myokardinfarkt Definition
    7)Jede Revaskularisation des Zielgefäßes
    8)Klinisch indizierte Revaskularisation des Zielgefäßes
    9)Jede Revaskularisation außerhalb des Zielgefäßes
    10)Klinisch indizierte Revaskularisation außerhalb des Zielgefäß
    11)Blutungsereignisse gemäß der BARC, TIMI und GUSTO Klassifizierung
    12)Transfusionsraten bei Patienten mit und/oder ohne klinisch nachgewiesener manifester Blutung
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 months after randomization
    14 Monate nach der Randomisierung
    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 Yes
    E.8.1.7.1Other trial design description
    Zeitlich verkürztes DAPT-Behandlungsschema
    Abbreviated DAPT regimen
    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
    verlängertes DAPT-Regime
    Prolonged DAPT regimen
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA70
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Bahrain
    Bangladesh
    Belgium
    Bulgaria
    Czech Republic
    Denmark
    Estonia
    France
    Hungary
    India
    Israel
    Italy
    Japan
    Kazakhstan
    Korea, Republic of
    Macedonia, the former Yugoslav Republic of
    Netherlands
    Poland
    Portugal
    Saudi Arabia
    Serbia
    Singapore
    Slovenia
    Spain
    Sweden
    Switzerland
    United Kingdom
    Vietnam
    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 years0
    E.8.9.1In the Member State concerned months14
    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 months14
    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.1.1.1In 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: 430
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3870
    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 2018-05-07. 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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2800
    F.4.2.2In the whole clinical trial 4300
    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 Decision2018-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-29
    P. End of Trial
    P.End of Trial StatusOngoing
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