Escalated Single Platelet Inhibition for One Month Plus NOAC in Patients With Atrial Fibrillation and ACS Undergoing PCI
NCT ID: NCT04981041
Last Updated: 2023-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
2334 participants
INTERVENTIONAL
2021-12-16
2025-06-16
Brief Summary
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However, approximately 30-40% of patients show low response to Clopidogrel and are not adequately protected against ischaemic events, in particular when presenting with ACS. This is supported by a recent meta-analysis reporting that TAT compared to DAT is associated with lower rates of stent thrombosis within 30 days after PCI. It is therefore reasonable to assume that a more potent platelet inhibition within the first month after PCI might reduce the rate of ischaemic complications observed in AF patients undergoing PCI, when receiving DAT. Moreover, a subsequent de-escalation to a less potent platelet inhibition one month after PCI might prevent an increase in bleeding complications.
In EPIDAURUS the investigators will therefore test the hypothesis that DAT using NOAC plus an escalated antiplatelet therapy with a potent P2Y12-inhibitor for one month followed by Clopidogrel reduces ischaemic events without a relevant increase in bleeding complications in patients with AF and ACS undergoing PCI compared to standard DAT with NOAC plus Clopidogrel.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Potent P2Y12-Inhibition
Prasugrel 10mg (5 mg in patients ≥ 75 years old or weighing \< 60 kg) q.d. per os or Ticagrelor 90mg bid per os
Prasugrel or Ticagrelor
Escalated antiplatelet therapy with a potent P2Y12- inhibitor for one month in patients with atrial fibrillation and indication for treatment non-vitamin K antagonist oral anticoagulants (NOACs)
Clopidogrel
Clopidogrel 75mg q.d. per os
Clopidogrel
Clopidogrel and NOAC
Interventions
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Prasugrel or Ticagrelor
Escalated antiplatelet therapy with a potent P2Y12- inhibitor for one month in patients with atrial fibrillation and indication for treatment non-vitamin K antagonist oral anticoagulants (NOACs)
Clopidogrel
Clopidogrel and NOAC
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Atrial fibrillation requiring oral anticoagulation
* STEMI or NSTEMI (biomarker positive acute coronary syndrome) and successful completion of PCI (randomization will take place within 24h after successful PCI)
Exclusion Criteria
* History of ischaemic stroke or transient ischaemic attack (both contraindications for Prasugrel) and history of intracranial bleeding (contraindication for Ticagrelor)
* Contraindication for Clopidogrel or Aspirin
* Contraindication for P2Y12-inhibitor
* Severe chronic liver disease (Child-Pugh C)
* Indication for oral anticoagulation with Vitamin K antagonists
* Moderate to severe mitral stenosis or mechanical heart valve
* Any bleeding BARC type ≥ 2 within the last 4 weeks before index procedure
* Pregnancy or lactation
* Inability to cooperate with the protocol requirements
* Life expectancy \< 6 months
* Participation in another investigational drug study
* Previous enrolment in this study
* For women of childbearing potential no negative pregnancy test and no agree to use a reliable method of birth control during the study
* Previous treatment with GP IIb/IIIa inhibitors within the last 12 hours
* A known genetic disorder involved in the metabolism of the study medication
18 Years
ALL
No
Sponsors
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Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Konstantinos Rizas
PD Dr. med. Konstantinos Rizas, Assistant Professor of Medicine, Co-Principal Investigator
Principal Investigators
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Steffen Massberg, MD
Role: PRINCIPAL_INVESTIGATOR
LMU Klinikum
Konstantinos Rizas, MD
Role: PRINCIPAL_INVESTIGATOR
LMU Klinikum
Locations
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Deutsches Herzzentrum München
Munich, Bavaria, Germany
Universitätsklinikum Freiburg, Universitäts-Herzzentrum Klinik für Kardiologie & Angiologie, Campus Bad Krozingen
Bad Krozingen, , Germany
Kerckhoff-Klinik GmbH, Herzzentrum
Bad Nauheim, , Germany
Campus Benjamin Franklin
Berlin, , Germany
Campus Virchow-Klinikum
Berlin, , Germany
Klinikum Bielefeld gem. GmbH Universitätsklinikum für Kardiologie und Internistische Intensivmedizin
Bielefeld, , Germany
Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden, Klinik für Innere Medizin und Kardiologie
Dresden, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Klinikum Landkreis Erding
Erding, , Germany
Universitätsklinikum Essen
Essen, , Germany
Universitäres Herzzentrum Universitätsklinikum Frankfurt am Main Goethe-Universität
Frankfurt am Main, , Germany
Universitätsklinikum Freiburg, Universitäts-Herzzentrum Klinik für Kardiologie & Angiologie, Campus Freiburg
Freiburg im Breisgau, , Germany
Evangelisches Krankenhaus Hagen-Haspe gGmbH, Klinik für Kardiologie und Rhythmologie
Hagen, , Germany
Medizinische Hochschule Hannover,Zentrum für Innere Medizin
Hanover, , Germany
Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie, Pneumologie
Heidelberg, , Germany
Universitätsklinikum Schleswig-Holstein -Campus Kiel- Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie, Angiologie und internistische Intensivmedizin
Kiel, , Germany
Herzzentrum Leipzig, Universitätsklinik für Kardiologie
Leipzig, , Germany
Universitätsmedizin Mainz, Zentrum für Kardiologie - Kardiologie I
Mainz, , Germany
LMU-Klinikum Campus Grosshadern
Munich, , Germany
LMU-Klinikum Campus Innenstadt
Munich, , Germany
Klinikum Nürnberg Süd, Klinik für Innere Medizin 8, Schwerpunkt Kardiologie
Nuremberg, , Germany
Universitätsmedizin Rostock, Zentrum Innere Medizin, Abteilung Kardiologie
Rostock, , Germany
HBK Hegau-Bodensee Klinikum Singen
Singen, , Germany
Barmherzige Brüder, Klinikum St. Elisabeth Straubing GmbH, II. Medizinische Klinik Innere Medizin, Kardiologie, Intensivmedizin, Pneumologie, Nephrologie und Angiologie
Straubing, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Countries
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Central Contacts
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Steffen Massberg, MD
Role: CONTACT
Facility Contacts
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Adnan Kastrati, Prof
Role: primary
Christoph Olivier, MD
Role: primary
Ulf Landmesser, Prof.
Role: primary
Frank Edelmann, Prof.
Role: primary
Christoph Stellbrink, Prof.
Role: primary
Axel Linke, Prof.
Role: primary
Amin Polzin, MD
Role: primary
Lorenz Bott-Flügel, MD
Role: primary
Amir Mahabadi, Prof
Role: primary
David Leistner, Prof.
Role: primary
Christoph Olivier, MD
Role: primary
Harilaos Bogossian, MD
Role: primary
Andreas Schäfer, Prof.
Role: primary
Norbert Frey, Prof.
Role: primary
Derk Frank, Prof.
Role: primary
Holger Thiele, Prof
Role: primary
Tommaso Gori, Prof.
Role: primary
Konstantinos Rizas, Prof.
Role: primary
Konstantinos Rizas, Prof.
Role: primary
Riza Sahin, MD
Role: primary
Hüsseyin Ince, Prof.
Role: primary
Marc Kollum, MD
Role: primary
Sebastian Maier, Prof.
Role: primary
Meinrad Gawaz, Prof.
Role: primary
Other Identifiers
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EPIDAURUS-2020
Identifier Type: -
Identifier Source: org_study_id
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