RecruitingPhase 4NCT04436978

What is the Optimal Antithrombotic Strategy in 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?


Sponsor

St. Antonius Hospital

Enrollment

2,000 participants

Start Date

Jan 11, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial looks for the best blood-thinning treatment strategy for people with atrial fibrillation (irregular heartbeat) who also need a stent procedure (PCI) for their heart. **You may be eligible if...** - You are 18 or older - You recently had a successful PCI (stent) procedure - You have atrial fibrillation or flutter requiring long-term blood thinners **You may NOT be eligible if...** - You cannot take edoxaban, aspirin, or all P2Y12 inhibitors - You need blood thinners for a reason other than atrial fibrillation - You had a stroke within the last 12 months - You have a mechanical heart valve, severe mitral valve disease, or a blood clot in the heart - You have very poor heart function, a history of brain bleeding, active bleeding, or severe kidney/liver problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUG30-day DAPT

DAPT (aspirin + P2Y12 inhibitor) during the first 30 days following PCI. After 30 days, all patients will be treated with edoxaban and a P2Y12 inhibitor.

DRUGGuideline-directed therapy

Guideline-directed therapy (edoxaban + P2Y12 inhibitor, aspirin limited to in-hospital use or up to 30 days in selected high-risk patients)


Locations(20)

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

UZ Leuven

Leuven, Belgium

AZ Delta

Roeselare, Belgium

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Amsterdam UMC

Amsterdam, Netherlands

OLVG

Amsterdam, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

Treant Zorggroep

Emmen, Netherlands

Zuyderland Ziekenhuis

Heerlen, Netherlands

Tergooi MC

Hilversum, Netherlands

St. Antonius Hospital

Nieuwegein, Netherlands

Hagaziekenhuis

The Hague, Netherlands

Elisabeth Tweesteden Ziekenhuis

Tilburg, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04436978


Related Trials