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Escalated Single Platelet Inhibition for One Month Plus NOAC in Patients With Atrial Fibrillation and ACS Undergoing PCI (EPIDAURUS)

Primary Purpose

Acute Coronary Syndrome, Atrial Fibrillation

Status
Recruiting
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Prasugrel or Ticagrelor
Clopidogrel
Sponsored by
Ludwig-Maximilians - University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent
  • 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:

  • Chronic renal insufficiency with glomerular filtration rate < 15 ml/min/1.73m2
  • 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

Sites / Locations

  • Deutsches Herzzentrum MünchenRecruiting
  • Universitätsklinikum Freiburg, Universitäts-Herzzentrum Klinik für Kardiologie & Angiologie, Campus Bad KrozingenRecruiting
  • Kerckhoff-Klinik GmbH, Herzzentrum
  • Campus Benjamin FranklinRecruiting
  • Campus Virchow-KlinikumRecruiting
  • Klinikum Bielefeld gem. GmbH Universitätsklinikum für Kardiologie und Internistische IntensivmedizinRecruiting
  • Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden, Klinik für Innere Medizin und KardiologieRecruiting
  • Universitätsklinikum DüsseldorfRecruiting
  • Klinikum Landkreis ErdingRecruiting
  • Universitätsklinikum EssenRecruiting
  • Universitäres Herzzentrum Universitätsklinikum Frankfurt am Main Goethe-UniversitätRecruiting
  • Universitätsklinikum Freiburg, Universitäts-Herzzentrum Klinik für Kardiologie & Angiologie, Campus FreiburgRecruiting
  • Evangelisches Krankenhaus Hagen-Haspe gGmbH, Klinik für Kardiologie und RhythmologieRecruiting
  • Medizinische Hochschule Hannover,Zentrum für Innere MedizinRecruiting
  • Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie, PneumologieRecruiting
  • Universitätsklinikum Schleswig-Holstein -Campus Kiel- Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie, Angiologie und internistische IntensivmedizinRecruiting
  • Herzzentrum Leipzig, Universitätsklinik für KardiologieRecruiting
  • Universitätsmedizin Mainz, Zentrum für Kardiologie - Kardiologie IRecruiting
  • LMU-Klinikum Campus GrosshadernRecruiting
  • LMU-Klinikum Campus InnenstadtRecruiting
  • Klinikum Nürnberg Süd, Klinik für Innere Medizin 8, Schwerpunkt KardiologieRecruiting
  • Universitätsmedizin Rostock, Zentrum Innere Medizin, Abteilung KardiologieRecruiting
  • HBK Hegau-Bodensee Klinikum SingenRecruiting
  • Barmherzige Brüder, Klinikum St. Elisabeth Straubing GmbH, II. Medizinische Klinik Innere Medizin, Kardiologie, Intensivmedizin, Pneumologie, Nephrologie und AngiologieRecruiting
  • Universitätsklinikum TübingenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Potent P2Y12-Inhibition

Clopidogrel

Arm Description

Prasugrel 10mg (5 mg in patients ≥ 75 years old or weighing < 60 kg) q.d. per os or Ticagrelor 90mg bid per os

Clopidogrel 75mg q.d. per os

Outcomes

Primary Outcome Measures

Major ischaemic events defined as the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke and systemic thromboembolism
superiority test
Bleeding type 2 or higher according to the Bleeding Academic Research Consortium (BARC) criteria
non-inferiority test

Secondary Outcome Measures

All-cause mortality
Myocardial infarction
Definite or probable stent thrombosis
Ischaemic stroke
Systemic thromboembolism
Cardiovascular mortality
Bleeding type 2 or more according to the Bleeding Academic Research Consortium
superiority testing
Urgent revascularization
All-cause mortality
Unplanned hospitalization due to acute heart failure or acute coronary syndrome
Ischaemic stroke

Full Information

First Posted
July 21, 2021
Last Updated
July 13, 2023
Sponsor
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT04981041
Brief Title
Escalated Single Platelet Inhibition for One Month Plus NOAC in Patients With Atrial Fibrillation and ACS Undergoing PCI
Acronym
EPIDAURUS
Official Title
Escalated Single Platelet Inhibition for One Month Plus Direct Oral Anticoagulation in Patients With Atrial Fibrillation and acUte coRonary Syndrome Undergoing percutaneoUS Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
December 16, 2024 (Anticipated)
Study Completion Date
June 16, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The selection of the optimal antithrombotic therapy in patients with nonvalvular atrial fibrillation (AF) and acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) is challenging. Until recently, triple antithrombotic therapy (TAT) consisting in Aspirin plus Clopidogrel plus OAC was considered the treatment of choice. While efficiently preventing ischaemic events, TAT is associated with an increase in bleeding complications. Therefore, in the past years several randomized controlled trials challenged TAT by comparing a triple antithrombotic therapy (TAT) regimen based on Vitamin K antagonists (VKA) to a dual antithrombotic regimen (DAT) based on non-vitamin K antagonist oral anticoagulants (NOACs) and P2Y12-inhibitors, mainly Clopidogrel in patients with AF undergoing PCI. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2334 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Potent P2Y12-Inhibition
Arm Type
Experimental
Arm Description
Prasugrel 10mg (5 mg in patients ≥ 75 years old or weighing < 60 kg) q.d. per os or Ticagrelor 90mg bid per os
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
Clopidogrel 75mg q.d. per os
Intervention Type
Drug
Intervention Name(s)
Prasugrel or Ticagrelor
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Clopidogrel and NOAC
Primary Outcome Measure Information:
Title
Major ischaemic events defined as the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke and systemic thromboembolism
Description
superiority test
Time Frame
6 weeks
Title
Bleeding type 2 or higher according to the Bleeding Academic Research Consortium (BARC) criteria
Description
non-inferiority test
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
6 weeks
Title
Myocardial infarction
Time Frame
6 weeks
Title
Definite or probable stent thrombosis
Time Frame
6 weeks
Title
Ischaemic stroke
Time Frame
6 weeks
Title
Systemic thromboembolism
Time Frame
6 weeks
Title
Cardiovascular mortality
Time Frame
6 weeks
Title
Bleeding type 2 or more according to the Bleeding Academic Research Consortium
Description
superiority testing
Time Frame
6 weeks
Title
Urgent revascularization
Time Frame
6 weeks
Title
All-cause mortality
Time Frame
6 months
Title
Unplanned hospitalization due to acute heart failure or acute coronary syndrome
Time Frame
6 months
Title
Ischaemic stroke
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent 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: Chronic renal insufficiency with glomerular filtration rate < 15 ml/min/1.73m2 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Konstantinos Rizas, MD
Phone
0049
Ext
89440073169
Email
konstantinos.rizas@med.uni-muenchen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Steffen Massberg, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Massberg, MD
Organizational Affiliation
LMU Klinikum
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Konstantinos Rizas, MD
Organizational Affiliation
LMU Klinikum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Herzzentrum München
City
Munich
State/Province
Bayern
ZIP/Postal Code
80636
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adnan Kastrati, Prof
First Name & Middle Initial & Last Name & Degree
Katharina Mayer, PD
Facility Name
Universitätsklinikum Freiburg, Universitäts-Herzzentrum Klinik für Kardiologie & Angiologie, Campus Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Olivier, MD
Facility Name
Kerckhoff-Klinik GmbH, Herzzentrum
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Campus Benjamin Franklin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulf Landmesser, Prof.
Facility Name
Campus Virchow-Klinikum
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Edelmann, Prof.
Facility Name
Klinikum Bielefeld gem. GmbH Universitätsklinikum für Kardiologie und Internistische Intensivmedizin
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Stellbrink, Prof.
Facility Name
Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden, Klinik für Innere Medizin und Kardiologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Axel Linke, Prof.
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amin Polzin, MD
Facility Name
Klinikum Landkreis Erding
City
Erding
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenz Bott-Flügel, MD
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Mahabadi, Prof
First Name & Middle Initial & Last Name & Degree
Tiennush Rassaf, Prof
Facility Name
Universitäres Herzzentrum Universitätsklinikum Frankfurt am Main Goethe-Universität
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Leistner, Prof.
Facility Name
Universitätsklinikum Freiburg, Universitäts-Herzzentrum Klinik für Kardiologie & Angiologie, Campus Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Olivier, MD
Facility Name
Evangelisches Krankenhaus Hagen-Haspe gGmbH, Klinik für Kardiologie und Rhythmologie
City
Hagen
ZIP/Postal Code
58135
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harilaos Bogossian, MD
Facility Name
Medizinische Hochschule Hannover,Zentrum für Innere Medizin
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Schäfer, Prof.
Facility Name
Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie, Pneumologie
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert Frey, Prof.
Facility Name
Universitätsklinikum Schleswig-Holstein -Campus Kiel- Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie, Angiologie und internistische Intensivmedizin
City
Kiel
ZIP/Postal Code
25105
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derk Frank, Prof.
Facility Name
Herzzentrum Leipzig, Universitätsklinik für Kardiologie
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holger Thiele, Prof
Facility Name
Universitätsmedizin Mainz, Zentrum für Kardiologie - Kardiologie I
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tommaso Gori, Prof.
Facility Name
LMU-Klinikum Campus Grosshadern
City
Munich
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinos Rizas, Prof.
Facility Name
LMU-Klinikum Campus Innenstadt
City
Munich
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinos Rizas, Prof.
Facility Name
Klinikum Nürnberg Süd, Klinik für Innere Medizin 8, Schwerpunkt Kardiologie
City
Nürnberg
ZIP/Postal Code
90471
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riza Sahin, MD
Facility Name
Universitätsmedizin Rostock, Zentrum Innere Medizin, Abteilung Kardiologie
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hüsseyin Ince, Prof.
Facility Name
HBK Hegau-Bodensee Klinikum Singen
City
Singen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Kollum, MD
Facility Name
Barmherzige Brüder, Klinikum St. Elisabeth Straubing GmbH, II. Medizinische Klinik Innere Medizin, Kardiologie, Intensivmedizin, Pneumologie, Nephrologie und Angiologie
City
Straubing
ZIP/Postal Code
94315
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Maier, Prof.
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meinrad Gawaz, Prof.
First Name & Middle Initial & Last Name & Degree
Dominik Rath, Prof

12. IPD Sharing Statement

Plan to Share IPD
No

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Escalated Single Platelet Inhibition for One Month Plus NOAC in Patients With Atrial Fibrillation and ACS Undergoing PCI

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