Optimal antithrombotic strategy for patients with atrial fibrillation undergoing PCI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the best antithrombotic management for patients with coronary artery disease and atrial fibrillation who are undergoing percutaneous coronary intervention. It compares the traditional triple antithrombotic therapy, which includes oral anticoagulation and dual antiplatelet therapy, against a newer dual antithrombotic therapy that omits aspirin. The goal is to determine a safer and equally effective treatment approach that minimizes the risk of major bleeding complications while preventing ischemic events. The study will enroll patients who meet specific criteria related to their atrial fibrillation and PCI status.

Why it matters

Who can join: the full rules

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

Where it's running

• ASZ Aalst
  Aalst, Belgium Recruiting
• UZ Antwerpen
  Antwerp, Belgium Recruiting
• Imelda Ziekenhuis
  Bonheiden, Belgium Recruiting
• UZ Brussel
  Brussels, Belgium Recruiting
• Ziekenhuis Oost-Limburg
  Genk, Belgium Recruiting
• AZ Maria Middelares Gent
  Ghent, Belgium Recruiting

Study contacts

• Principal investigator: Jurriën M ten Berg, Prof, MD — St. Antonius Hospital
• Study coordinator: Ashley Verburg, MD
• Email: as.verburg@antoniusziekenhuis.nl
• Phone: +31 (0)88 320 0925

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.