NCT04981041: EPIDAURUS

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

Status unknown Phase 4 Last updated 14 July 2023

What this trial tests

Phase 4 trial testing Prasugrel or Ticagrelor in Acute Coronary Syndrome in 2,334 participants. Status unknown.

Timeline

16 December 2021

Primary endpoint
16 December 2024

16 June 2025

Quick facts

Lead sponsor	Ludwig-Maximilians - University of Munich
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	2,334
Start date	16 December 2021
Primary completion	16 December 2024
Estimated completion	16 June 2025
Sites	25 locations across Germany

Drugs / interventions tested

• Prasugrel or Ticagrelor — full drug profile →
• Clopidogrel (clopidogrel) — full drug profile →

Conditions studied

• Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Ludwig-Maximilians - University of Munich

Who can join

18 and older, any sex, with Acute Coronary Syndrome or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antithrombotic Management in AF Patients Following Percutaneous Coronary Intervention: A European Perspective.
   Greco A, Laudani C, Rochira C, Capodanno D. · · 2023 · cited 12× · PMID 37601736 · DOI 10.15420/icr.2021.30
2. Temporary omission of oral anticoagulation in atrial fibrillation patients undergoing percutaneous coronary intervention: rationale and design of the WOEST-3 randomised trial.
   Verburg A, Bor WL, Küçük IT, Henriques JPS, et al · · 2024 · cited 7× · PMID 39007830 · DOI 10.4244/eij-d-24-00100
3. Duration of triple antithrombotic therapy and clinical outcomes after percutaneous coronary intervention in atrial fibrillation.
   Sammut MA, Conway D, Iqbal J, Krishnamurthy A, et al · · 2024 · cited 1× · PMID 38949642 · DOI 10.1080/14779072.2024.2374366