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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)
EU CTIS ID: 2024-512727-36-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 flow grade 2 or more; randomization will take place within 5 days (recommended within 24h) after successful PCI and before hospital discharge)
You likely can't join if
- Chronic renal insufficiency with glomerular filtration rate < 15 ml/min/1.73m2
- 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
See the full eligibility 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 flow grade 2 or more; randomization will take place within 5 days (recommended within 24h) after successful PCI and before hospital discharge)
- Chronic renal insufficiency with glomerular filtration rate < 15 ml/min/1.73m2
- 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
- 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 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.