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What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI?

RecruitingPhase 4Ages 18 Years - anyAllSt. Antonius Hospital
NCT04436978 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The optimal antithrombotic management in patients with coronary artery disease (CAD) and concomitant atrial fibrillation (AF) is unknown. AF patients are treated with oral anticoagulation (OAC) to prevent ischemic stroke and systemic embolism and patients undergoing percutaneous coronary intervention (PCI) are treated with dual antiplatelet therapy (DAPT), i.e. aspirin plus P2Y12 inhibitor, to prevent stent thrombosis (ST) and myocardial infarction (MI). Patients with AF undergoing PCI were traditionally treated with triple antithrombotic therapy (TAT, i.e. OAC plus aspirin and P2Y12 inhibitor) to prevent ischemic complications. However, TAT doubles or even triples the risk of major bleeding complications. More recently, several clinical studies demonstrated that omitting aspirin, a strategy known as dual antithrombotic therapy (DAT) is safer compared to TAT with comparable efficacy. Ho

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients ≥ 18 years 2. Undergoing successful PCI (either ACS or elective PCI) 3. History of or newly diagnosed (\<72 hours after PCI/ACS) atrial fibrillation or flutter with a long-term (≥ 1 year) indication for OAC Exclusion Criteria: 1. Contra indication to edoxaban, aspirin or all P2Y12 inhibitors 2. Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism) 3. \<12 months after any stroke 4. CHADSVASc score ≥7 5. Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2) 6. Mechanical heart valve prosthesis 7. Intracardiac thrombus or apical aneurysm requiring OAC 8. Poor LV function (LVEF \<30%) with proven slow-flow 9. History of intracranial haemorrhage 10. Active bleeding on randomization 11. History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding, unless the causative factor has been permanently resolved 12. Recent (\<1 month) gastrointestinal haemorrhage, unless the causative factor has been permanently resolved. 13. Known coagulopathy 14. Severe anaemia requiring blood transfusion or thrombocytopenia \<50 × 109/L 15. BMI \>40 or bariatric surgery 16. Kidney failure (eGFR \<15) 17. Active liver disease (ALT, ASP, AP \>3x ULN or active hepatitis A, B or C) 18. Active malignancy excluding non-melanoma skin cancer 19. Life expectancy \<1 year 20. Pregnancy or breast-feeding women
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What it tests

  • 30-day DAPT
  • Guideline-directed therapy
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Where

20 sites
ASZ Aalst
Aalst, Belgium
UZ Antwerpen
Antwerp, Belgium
Imelda Ziekenhuis
Bonheiden, Belgium
UZ Brussel
Brussels, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
AZ Maria Middelares Gent
Ghent, Belgium
Jan Yperman
Ieper, Belgium
AZ Groeninge
Kortrijk, Belgium

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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