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Completed

NCT Number: NCT04981041

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

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.

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Key information

Conditions

Acute Coronary Syndrome Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prasugrel or ticagrelor

Drug

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

Drug

Clopidogrel and NOAC

Primary outcomes

  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

    Time frame: 6 weeks

    superiority test

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

    Time frame: 6 weeks

    non-inferiority test

Secondary outcomes

  1. All-cause mortality

    Time frame: 6 weeks

  2. Myocardial infarction

    Time frame: 6 weeks

  3. Definite or probable stent thrombosis

    Time frame: 6 weeks

  4. Ischaemic stroke

    Time frame: 6 weeks

  5. Systemic thromboembolism

    Time frame: 6 weeks

  6. Cardiovascular mortality

    Time frame: 6 weeks

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

    Time frame: 6 weeks

    superiority testing

  8. Urgent revascularization

    Time frame: 6 weeks

  9. All-cause mortality

    Time frame: 6 months

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

    Time frame: 6 months

  11. Ischaemic stroke

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study 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

Acronym: EPIDAURUS

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2021
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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