NCT04436978 What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI?
| NCT ID | NCT04436978 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | St. Antonius Hospital |
| Condition | Acute Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2023-01-11 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,000 participants in total. It began in 2023-01-11 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. However, pooled evidence from recent meta-analyses suggests that patients treated with DAT are at increased risk of MI and ST. Insights from the AUGUSTUS trial showed that aspirin added to OAC and clopidogrel for 30 days, but not thereafter, resulted in fewer severe ischemic events. This finding emphasizes the relevance of early aspirin administration on ischemic benefit, also reflected in the current ESC guideline. However, because we consider the bleeding risk of TAT unacceptably high, we propose to use a short course of DAPT (omitting OAC for 1 month). There is evidence from the BRIDGE study that a short period of omitting OAC is safe in patients with AF. In this study, these patients are treated with DAPT, which also prevents stroke, albeit not as effective as OAC. This temporary interruption of OAC will allow aspirin treatment in the first month post-PCI where the risk of both bleeding and stent thrombosis is greatest. The WOEST 3 trial is a multicentre, open-label, randomised controlled trial investigating the safety and efficacy of one month DAPT compared to guideline-directed therapy consisting of OAC and P2Y12 inhibitor combined with aspirin up to 30 days. We hypothesise that the use of short course DAPT is superior in bleeding and non-inferior in preventing ischemic events. The primary safety endpoint is major or clinically relevant non-major bleeding as defined by the ISTH at 6 weeks after PCI. The primary efficacy endpoint is a composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis at 6 weeks after PCI.
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
Contact & Investigator
Jurriën M ten Berg, Prof, MD
PRINCIPAL INVESTIGATOR
St. Antonius Hospital
Frequently Asked Questions
Who can join the NCT04436978 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04436978 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04436978 currently recruiting?
Yes, NCT04436978 is actively recruiting participants. Contact the research team at as.verburg@antoniusziekenhuis.nl for enrollment information.
Where is the NCT04436978 trial being conducted?
This trial is being conducted at Aalst, Belgium, Antwerp, Belgium, Bonheiden, Belgium, Brussels, Belgium and 11 additional locations.
Who is sponsoring the NCT04436978 clinical trial?
NCT04436978 is sponsored by St. Antonius Hospital. The principal investigator is Jurriën M ten Berg, Prof, MD at St. Antonius Hospital. The trial plans to enroll 2,000 participants.