30-day DAPT
DrugDAPT (aspirin + P2Y12 inhibitor) during the first 30 days following PCI. After 30 days, all patients will be treated with edoxaban and a P2Y12 inhibitor.
NCT Number: NCT04436978
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
ASZ Aalst, Aalst, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Guideline-directed therapy (edoxaban + P2Y12 inhibitor, aspirin limited to in-hospital use or up to 30 days in selected high-risk patients)
Time frame: 6 weeks
Major or clinically relevant non-major bleeding as defined by the International Society of Thrombosis and Haemostasis
Time frame: 6 weeks
Composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis
Time frame: 6 months
Major or clinically relevant non-major bleeding as defined by the International Society of Thrombosis and Haemostasis
Time frame: 6 months
Composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis
Time frame: 6 weeks, 3 months, 6 months
Composite of major bleeding, myocardial infarction, stroke, systemic embolism all-cause death and stent thrombosis
Time frame: 6 weeks, 3 months, 6 months
CCS grade
Time frame: 6 weeks, 3 months, 6 months
All-cause death as defined by ARC-2 and SCTI
Time frame: 6 weeks, 3 months, 6 months
Myocardial infarction as defined by the 4th Universal Definition of Myocardial Infarction
Time frame: 6 weeks, 3 months, 6 months
Stroke as defined by VARC-2 definitions
Time frame: 6 weeks, 3 months, 6 months
Systemic embolism according to ENTRUST-AF PCI definition
Time frame: 6 weeks, 3 months, 6 months
Stent thrombosis as defined by ARC-2
Time frame: 6 weeks, 3 months, 6 months
Major bleeding as defined by BARC 3 or 5
Time frame: 6 weeks, 3 months, 6 months
CRNM as defined by BARC 2
Time frame: 6 weeks, 3 months, 6 months
EuroQol-5D-5L questionnaire
Contact information is provided by the study sponsor or research team.
St. Antonius Hospital
Other
What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Having Acute Coronary Syndrome or Undergoing Percutaneous Coronary Intervention?
Acronym: WOEST-3
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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