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Search / Trial NCT04436978

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

Launched by ST. ANTONIUS HOSPITAL · Jun 16, 2020

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Acute Coronary Syndrome Myocardial Infarction Atrial Fibrillation Atrial Flutter Stemi St Elevation Myocardial Infarction Nstemi Non St Segment Elevation Mi Oral Anticoagulant Noac Novel Oral Anticoagulant Doac Direct Oral Anticoagulant Dapt Dual Antiplatelet Therapy Antithrombotic Therapy Dual Therapy Triple Therapy Bleeding Thrombosis Stroke Stent Thrombosis Systemic Embolism Percutaneous Coronary Intervention Coronary Artery Disease

ClinConnect Summary

The WOEST 3 trial is studying the best way to prevent blood clots in patients with atrial fibrillation (AF) who are undergoing a procedure called percutaneous coronary intervention (PCI), often used to treat blocked arteries. Typically, patients with AF take medications to prevent strokes, but after PCI, they may need additional medications to prevent complications like heart attacks or stent blockages. This trial is exploring whether a short course of dual antithrombotic therapy (DAPT) — which includes two types of blood-thinning medications — is safer and just as effective as the standard approach, which involves a combination of three medications (triple antithrombotic therapy or TAT). Researchers believe that using DAPT for a month may reduce the risk of bleeding while still protecting against serious heart problems.

To be eligible for this trial, participants must be at least 18 years old, have recently undergone a successful PCI, and have a history of atrial fibrillation that requires long-term treatment with blood thinners. Participants will be closely monitored for any bleeding issues and heart-related problems over a six-week period after the procedure. This trial is important because it may help determine a safer treatment strategy for patients with both AF and coronary artery disease.

Gender

ALL

Eligibility criteria

  • 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

About St. Antonius Hospital

St. Antonius Hospital is a leading healthcare institution dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a strong emphasis on collaboration, the hospital brings together a multidisciplinary team of experts to conduct high-quality research across various therapeutic areas. Committed to ethical standards and patient safety, St. Antonius Hospital aims to contribute to the development of new treatments and therapies that enhance the quality of care for its diverse patient population. Through its robust clinical trial program, the hospital seeks to translate scientific discoveries into tangible health benefits.

Locations

Amsterdam, , Netherlands

Eindhoven, , Netherlands

Eindhoven, , Netherlands

Den Haag, , Netherlands

Leuven, , Belgium

Leuven, , Belgium

Nieuwegein, , Netherlands

Antwerpen, , Belgium

Brussel, , Belgium

Genk, , Belgium

Bonheiden, , Belgium

Aalst, , Belgium

Kortrijk, , Belgium

Gent, , Belgium

Aalst, , Belgium

Alkmaar, , Netherlands

Roeselare, , Belgium

Tilburg, , Netherlands

Emmen, , Netherlands

Amsterdam, , Netherlands

Heerlen, , Netherlands

Hilversum, , Netherlands

Ieper, , Belgium

Patients applied

0 patients applied

Trial Officials

Jurriën M ten Berg, Prof, MD

Principal Investigator

St. Antonius Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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