Patients who are diagnosed with atrial fibrillation and experienced an acute myocardial infarction treated with percutaneos coronary intervention will receive an intesified treatment combination of platelet inihibition and direct oral anticoagulation.

Escalated single platelet inhibition for one month plus direct oral anticoagulation in patients with atrial fibrillation and acute coronary syndrome undergoing percutaneous coronary intervention - EPIDAURUS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004748-27-AT

Enrollment

2334

Registered

2022-01-20

Start date

2022-04-21

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with atrial fibrillation and ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) (biomarker -positive acute coronary syndrome) undergoing PCI MedDRA version: 20.0 Level: PT Classification code 10028596 Term: Myocardial infarction System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: Prasugrel Pharmaceutical Form: Film-coated tablet INN or Proposed INN: PRASUGREL CAS Number: 150322-43-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Written informed consent • Age = 18 years • Atrial fibrillation requiring oral anticoagulation • STEMI or NSTEMI (biomarker positive acute coronary syndrome) • Successful completion of PCI (defined as TIMI grade 2 or more); randomization will take place within 5 days (recommended within 24h) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1634

Exclusion criteria

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 Clopidogrel or Aspirin • Contraindication for Prasugrel and Ticagrelor • 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 • Any other reason in the opinion of the investigator making the patient ineligible for participation in the trial

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary study objective is to test whether an escalated antiplatelet therapy with a potent P2Y12-inhibitor (Prasugrel or Ticagrelor) for 4 weeks can reduce ischaemic events without a significant increase in bleeding complications in patients with atrial fibrillation and ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation acute coronary myocardial infarction (NSTEMI) (biomarker -positive acute coronary syndrome) undergoing PCI.;Secondary Objective: The effect of platelet function based on platelet function testing (PFT) on ischaemic and bleeding complications will be investigated in a pre-defined substudy.;Primary end point(s): Primary endpoints at 6 weeks after randomization (hierarchical testing) •Efficacy: Major ischaemic events defined as the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke or systemic thromboembolism (superiority test) •Safety: Bleeding type 2 or higher according to the Bleeding Academic Research Consortium (BARC) criteria (non-inferiority test) ;Timepoint(s) of evaluation of this end point: At 6 weeks after randomization	—

Measure

Time frame

Main Objective: The primary study objective is to test whether an escalated antiplatelet therapy with a potent P2Y12-inhibitor (Prasugrel or Ticagrelor) for 4 weeks can reduce ischaemic events without a significant increase in bleeding complications in patients with atrial fibrillation and ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation acute coronary myocardial infarction (NSTEMI) (biomarker -positive acute coronary syndrome) undergoing PCI.;Secondary Objective: The effect of platelet function based on platelet function testing (PFT) on ischaemic and bleeding complications will be investigated in a pre-defined substudy.;Primary end point(s): Primary endpoints at 6 weeks after randomization (hierarchical testing) •Efficacy: Major ischaemic events defined as the composite of all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke or systemic thromboembolism (superiority test) •Safety: Bleeding type 2 or higher according to the Bleeding Academic Research Consortium (BARC) criteria (non-inferiority test) ;Timepoint(s) of evaluation of this end point: At 6 weeks after randomization

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Secondary

Measure	Time frame
Secondary end point(s): • All individual components of the primary endpoint (all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke, systemic thromboembolism) at 6 weeks after randomization • Cardiovascular mortality at 6 weeks after randomization • Bleeding (BARC type = 2) at 6 weeks after randomization • Urgent revascularization at 6 weeks after randomization • All-cause mortality at 6 months after randomization • Unplanned hospitalization due to acute heart failure or acute coronary syndrome at 6 months after randomization • Ischaemic stroke at 6 months after randomization;Timepoint(s) of evaluation of this end point: At 6 weeks after randomization: All individual components of the primary endpoint (all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke, systemic thromboembolism) • Cardiovascular mortality • Bleeding (BARC type = 2) • Urgent revascularization At 6 months: • All-cause mortality • Unplanned hospitalization due to acute heart failure or acute coronary syndrome • Ischaemic stroke	—

Measure

Time frame

Secondary end point(s): • All individual components of the primary endpoint (all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke, systemic thromboembolism) at 6 weeks after randomization • Cardiovascular mortality at 6 weeks after randomization • Bleeding (BARC type = 2) at 6 weeks after randomization • Urgent revascularization at 6 weeks after randomization • All-cause mortality at 6 months after randomization • Unplanned hospitalization due to acute heart failure or acute coronary syndrome at 6 months after randomization • Ischaemic stroke at 6 months after randomization;Timepoint(s) of evaluation of this end point: At 6 weeks after randomization: All individual components of the primary endpoint (all-cause mortality, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke, systemic thromboembolism) • Cardiovascular mortality • Bleeding (BARC type = 2) • Urgent revascularization At 6 months: • All-cause mortality • Unplanned hospitalization due to acute heart failure or acute coronary syndrome • Ischaemic stroke

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Countries

Albania, Austria

Contacts

Public ContactProf. Dr. med. Konstantinos Rizas

LMU University Hospital Munich

konstantinos.rizas@med.uni-muenchen.de0049894400 73169

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026