What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Having Acute Coronary Syndrome or Undergoing Percutaneous Coronary Intervention?

Who is this study for? Patients with acute coronary syndrome or percutaneous coronary intervention and atrial fibrillation
What treatments are being studied? Dual antiplatelet therapy
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients ≥ 18 years

• Undergoing successful PCI (either ACS or elective PCI)

• History of or newly diagnosed (\<72 hours after PCI/ACS) atrial fibrillation or flutter with a long-term (≥ 1 year) indication for OAC

Locations
Other Locations
Belgium
ASZ Aalst
RECRUITING
Aalst
UZ Antwerpen
RECRUITING
Antwerp
Imelda Ziekenhuis
RECRUITING
Bonheiden
UZ Brussel
RECRUITING
Brussels
Ziekenhuis Oost-Limburg
RECRUITING
Genk
AZ Maria Middelares Gent
RECRUITING
Ghent
Jan Yperman
NOT_YET_RECRUITING
Ieper
AZ Groeninge
RECRUITING
Kortrijk
UZ Leuven
RECRUITING
Leuven
AZ Delta
RECRUITING
Roeselare
Netherlands
Noordwest Ziekenhuisgroep
RECRUITING
Alkmaar
Amsterdam UMC
RECRUITING
Amsterdam
OLVG
RECRUITING
Amsterdam
Catharina Ziekenhuis
RECRUITING
Eindhoven
Treant Zorggroep
RECRUITING
Emmen
Zuyderland Ziekenhuis
NOT_YET_RECRUITING
Heerlen
Tergooi MC
RECRUITING
Hilversum
St. Antonius Hospital
RECRUITING
Nieuwegein
Hagaziekenhuis
RECRUITING
The Hague
Elisabeth Tweesteden Ziekenhuis
RECRUITING
Tilburg
Contact Information
Primary
Ashley Verburg, MD
as.verburg@antoniusziekenhuis.nl
+31 (0)88 320 0925
Time Frame
Start Date: 2023-01-11
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 2000
Treatments
Active_comparator: First month DAPT
30-day DAPT (aspirin + P2Y12 inhibitor). After 30 days all patients will be treated with edoxaban and P2Y12 inhibitor.~Selection of P2Y12 inhibitor is at the discretion of the treating physician, depending on both bleeding and ischemic risk. Dosage of aspirin and P2Y12 inhibitor is according to local guidelines.~NOAC of choice will be edoxaban. Patients will be treated with the recommended dose of 60mg once daily or the reduced dose of 30mg once daily.
Active_comparator: Guideline-directed therapy
Standard guideline-directed therapy (edoxaban + P2Y12 inhibitor, aspirin limited to in-hospital use or up to 30 days in selected high-risk patients). After 30 days all patients will be treated with edoxaban and P2Y12 inhibitor.~Selection of P2Y12 inhibitor is at the discretion of the treating physician, depending on both bleeding and ischemic risk. Dosage of aspirin and P2Y12 inhibitor is according to local guidelines.~NOAC of choice will be edoxaban. Patients will be treated with the recommended dose of 60mg once daily or the reduced dose of 30mg once daily.
Sponsors
Collaborators: Daiichi Sankyo
Leads: St. Antonius Hospital

This content was sourced from clinicaltrials.gov

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