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New antithrombotic therapy for patients with atrial fibrillation and acute coronary syndrome undergoing PCI

Escalated Single Platelet Inhibition for One Month Plus Direct Oral Anticoagulation in Patients With Atrial Fibrillation and acUte coRonary Syndrome Undergoing percutaneoUS Coronary Intervention

Phase 4 Interventional Ludwig-Maximilians - University of Munich · NCT04981041

This study is testing a new combination of blood thinners to see if it can help patients with atrial fibrillation and heart issues during a heart procedure, while reducing the risk of bleeding compared to standard treatments.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment2334 (estimated)
Ages18 Years and up
SexAll
SponsorLudwig-Maximilians - University of Munich Academic / other
Locations25 sites (Munich, Bayern and 24 other locations)
Trial IDNCT04981041 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of escalated single platelet inhibition combined with non-vitamin K antagonist oral anticoagulants (NOACs) in patients with atrial fibrillation (AF) and acute coronary syndrome (ACS) who are undergoing percutaneous coronary intervention (PCI). The study aims to compare the safety and efficacy of dual antithrombotic therapy against traditional triple antithrombotic therapy, which has been associated with increased bleeding complications. Participants will be randomized within 24 hours after successful PCI, focusing on those who may not respond adequately to standard treatments. The goal is to optimize antithrombotic therapy while minimizing risks for patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with atrial fibrillation requiring oral anticoagulation and who have experienced STEMI or NSTEMI and undergone successful PCI.

Not a fit: Patients with contraindications to the study medications, severe chronic liver disease, or those with a life expectancy of less than six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the risk of ischemic events while minimizing bleeding complications for patients with AF and ACS.

How similar studies have performed: Previous studies have explored dual antithrombotic regimens, indicating potential benefits, but this specific approach is novel in its focus on escalated single platelet inhibition combined with NOACs.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Munich, Bayern and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Coronary SyndromeAtrial Fibrillation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.