Optimal antithrombotic strategy for patients with atrial fibrillation undergoing PCI
What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Having Acute Coronary Syndrome or Undergoing Percutaneous Coronary Intervention?
This study is testing whether a new blood-thinning treatment for patients with atrial fibrillation undergoing heart procedures is safer and just as effective as the traditional approach that includes more medications.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Antonius Hospital Academic / other |
| Locations | 20 sites (Aalst and 19 other locations) |
| Trial ID | NCT04436978 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 and older who are undergoing successful PCI and have a history of or newly diagnosed atrial fibrillation or flutter with a long-term need for oral anticoagulation.
Not a fit: Patients with contraindications to the study medications or those with severe comorbidities such as recent strokes or significant bleeding history may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer treatment options for patients with atrial fibrillation undergoing PCI, reducing the risk of bleeding complications.
How similar studies have performed: Recent studies have shown promising results with dual antithrombotic therapy, suggesting that this approach may be safer than traditional triple therapy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalst and 19 other locations
- 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)
- Jan Yperman — Ieper, Belgium (Not_yet_recruiting)
- AZ Groeninge — Kortrijk, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- AZ Delta — Roeselare, Belgium (Recruiting)
- Noordwest Ziekenhuisgroep — Alkmaar, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Olvg — Amsterdam, Netherlands (Recruiting)
- Catharina Ziekenhuis — Eindhoven, Netherlands (Recruiting)
- Treant Zorggroep — Emmen, Netherlands (Recruiting)
- Zuyderland Ziekenhuis — Heerlen, Netherlands (Not_yet_recruiting)
- Tergooi MC — Hilversum, Netherlands (Recruiting)
- St. Antonius Hospital — Nieuwegein, Netherlands (Recruiting)
- Hagaziekenhuis — The Hague, Netherlands (Recruiting)
- Elisabeth Tweesteden Ziekenhuis — Tilburg, Netherlands (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.