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AzTrials

Acute Coronary SyndromePhase 4EPIDAURUSNCT04981041

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

A Phase 4 study testing Prasugrel or Ticagrelor and Clopidogrel in people with Acute Coronary Syndrome and Atrial Fibrillation, run by Ludwig-Maximilians - University of Munich at 37 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome, Atrial Fibrillation
What is being tested?
Prasugrel or Ticagrelor and Clopidogrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
602 participants
Where
37 sitesin 2 countries
Study dates
16 Dec 2021to 30 May 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

Germany36 sites

  • Universitätsklinikum Freiburg, Universitäts-Herzzentrum Klinik für Kardiologie & Angiologie, Campus Bad Krozingen

    Bad Krozingen, 79189

  • Kerckhoff-Klinik GmbH, Herzzentrum

    Bad Nauheim, 61231

  • Campus Benjamin Franklin

    Berlin

  • Campus Virchow-Klinikum

    Berlin

  • Sana Klinikum Lichtenberg Klinik für Innere Medizin II: Kardiologie Fanningerstraße 32 10365 Berlin

    Berlin

  • Klinikum Bielefeld gem. GmbH Universitätsklinikum für Kardiologie und Internistische Intensivmedizin

    Bielefeld, 33604

  • Universitätsklinikum Bonn (AöR) Medizinische Klinik und Poliklinik II - Herzzentrum Venusberg-Campus 1 53127 Bonn

    Bonn

  • Klinikum Coburg, Kardiologie-Angiologie Ketschendorfer Str. 33 96450 Coburg

    Coburg

  • Helios Amper-Klinikum Dachau Kardiologie und Pneumologie Krankenhausstraße 15 85221 Dachau

    Dachau

  • Herzzentrum Dresden GmbH Universitätsklinik an der Technischen Universität Dresden, Klinik für Innere Medizin und Kardiologie

    Dresden, 01307

  • Universitätsklinikum Düsseldorf

    Düsseldorf

  • Klinikum Landkreis Erding

    Erding

  • Universitätsklinikum Essen

    Essen

  • Universitäres Herzzentrum Universitätsklinikum Frankfurt am Main Goethe-Universität

    Frankfurt am Main, 60590

  • Universitätsklinikum Freiburg, Universitäts-Herzzentrum Klinik für Kardiologie & Angiologie, Campus Freiburg

    Freiburg im Breisgau, 79106

  • Klinikum Friedrichshafen, Medizin Campus Bodensee Klinik für Kardiologie, Angiologie, Pneumologie und internistische Intensivmedizin Röntgenstraße 2 88048 Friedrichshafen

    Friedrichshafen

  • Evangelisches Krankenhaus Hagen-Haspe gGmbH, Klinik für Kardiologie und Rhythmologie

    Hagen, 58135

  • Medizinische Hochschule Hannover,Zentrum für Innere Medizin

    Hanover, 30625

  • Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie, Pneumologie

    Heidelberg, 69120

  • Klinikum Ingolstadt Medizinische Klinik I Krumenauerstraße 25 85049 Ingolstadt

    Ingolstadt

  • Universitätsklinikum Schleswig-Holstein -Campus Kiel- Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie, Angiologie und internistische Intensivmedizin

    Kiel, 25105

  • Klinikum Konstanz Medizinische Klinik, Studienzentrum Mainaustr. 35 78464 Konstanz

    Konstanz

  • Herzzentrum Leipzig, Universitätsklinik für Kardiologie

    Leipzig, 04289

  • Universitätsklinikum Schleswig-Holstein (UKSHL) Campus Lübeck Medizinische Klinik II (Kardiologie, Angiologie, Intensivmedizin) Universitäres Herzzentrum Lübeck Ratzeburger Allee 160 23538 Lübeck, Deutschland

    Lübeck

  • Universitätsmedizin Mainz, Zentrum für Kardiologie - Kardiologie I

    Mainz, 55131

  • Universitätsklinikum Mannheim Medizinische Klinik Kardiologie, Angiologie, Hämostaseologie, Internistische Intensivmedizin Theodor-Kutzer-Ufer 1-3 68167 Mannheim

    Mannheim

  • München Klinik Bogenhausen, Klinik für Kardiologie und Internistische Intensivmedizin

    München

  • Deutsches Herzzentrum München

    Munich, Bavaria, 80636

  • LMU-Klinikum Campus Grosshadern

    Munich, 81377

  • LMU-Klinikum Campus Innenstadt

    Munich

  • Klinikum Nürnberg Süd, Klinik für Innere Medizin 8, Schwerpunkt Kardiologie

    Nuremberg, 90471

  • St. Vincenz Krankenhaus Paderborn Medizinische Klinik II Kardiologie und internistische Intensivmedizin Am Busdorf 2 33098 Paderborn

    Paderborn

  • Universitätsmedizin Rostock, Zentrum Innere Medizin, Abteilung Kardiologie

    Rostock, 18057

  • HBK Hegau-Bodensee Klinikum Singen

    Singen

  • Barmherzige Brüder, Klinikum St. Elisabeth Straubing GmbH, II. Medizinische Klinik Innere Medizin, Kardiologie, Intensivmedizin, Pneumologie, Nephrologie und Angiologie

    Straubing, 94315

  • Universitätsklinikum Tübingen

    Tübingen

Other trials in Germany

Austria1 site

  • Medizinische Universität Innsbruck Universitätsklinik für Innere Medizin III - Kardiologie und Angiologie Anichstraße 35 6020 Innsbruck, Austria

    Innsbruck

Other trials in Austria

About this study

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

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.

Being tested
Prasugrel or Ticagrelor, Clopidogrel
Medical subject headings
Acute Coronary Syndrome, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prasugrel or TicagrelorDrug

    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)

  • ClopidogrelDrug

    Clopidogrel and NOAC

Study groups in NCT04981041
Study groupRoleWhat they receive
Potent P2Y12-InhibitionExperimentalPrasugrel 10mg (5 mg in patients ≥ 75 years old or weighing < 60 kg) q.d. per os or Ticagrelor 90mg bid per os
Receives: Drug: Prasugrel or Ticagrelor
ClopidogrelActive comparatorClopidogrel 75mg q.d. per os
Receives: Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major ischaemic events defined as the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke systemic thromboembolism and urgent revascularization

    superiority test

    Measured: 6 weeks

  2. Death and Bleeding type 2 or higher according to the Bleeding Academic Research Consortium (BARC) criteria

    non-inferiority test

    Measured: 6 weeks

Secondary outcomes (11)

  1. All-cause mortality

    Measured: 6 weeks

  2. Myocardial infarction

    Measured: 6 weeks

  3. Definite or probable stent thrombosis

    Measured: 6 weeks

  4. Ischaemic stroke

    Measured: 6 weeks

  5. Systemic thromboembolism

    Measured: 6 weeks

  6. Cardiovascular mortality

    Measured: 6 weeks

  7. Bleeding type 2 or more according to the Bleeding Academic Research Consortium

    superiority testing

    Measured: 6 weeks

  8. Urgent revascularization

    Measured: 6 weeks

  9. All-cause mortality

    Measured: 6 months

  10. Unplanned hospitalization due to acute heart failure or acute coronary syndrome

    Measured: 6 months

  11. Ischaemic stroke

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2021
  2. Study start16 Dec 2021
  3. Primary completion22 May 2026
  4. Study completion30 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
602 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04981041
Sponsor's protocol ID
EPIDAURUS-2020
Acronym
EPIDAURUS
Status last verified
May 2026
First submitted
21 Jul 2021
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rizas KD, Mourouzis K, Rath D, Olivier CB, Villegas Sierra LE, Korovesis T, Polzin A, Tawil AA, Wakili R, von Stuelpnagel L, Mayer K, Janisch M, Ulrich T, Lang S, Maier SKG, Brattinger F, Bott-Flugel L, Bogossian H, Iliodromitis K, Freyer L, Steffen J, Stark K, Eiffener E, Sams LE, Petzold T, Linke A, Heidrich FM, Sossala S, Zako S, Dagkonakis N, Schafer A, Edelmann F, Leistner DM, Maslarska M, Knebel F, Nickenig G, Luani B, Rassaf T, Ince H, Akin I, Maeder MT, Gawaz M, Feistritzer HJ, Frey N, Kaab S, Sahin R, Pauschinger M, Stiermaier T, Eitel I, Kollum M, Wolter JS, Schreinlechner M, Bauer A, Stellbrink C, Landmesser U, Kirchhof P, Sibbing D, Thiele H, Kastrati A, Mansmann U, Massberg S. Dual antithrombotic therapy using potent antiplatelet inhibitors in atrial fibrillation and acute coronary syndrome: a randomized controlled trial. Nat Med. 2026 Aug 29. doi: 10.1038/s41591-026-04629-7. Online ahead of print.

    PubMed 42668287

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prasugrel or Ticagrelor and Clopidogrel in people with Acute Coronary Syndrome and Atrial Fibrillation, run by Ludwig-Maximilians - University of Munich at 37 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major ischaemic events defined as the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke systemic thromboembolism and urgent revascularization (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04981041, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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