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What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI?

Study acronym: WOEST-3
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Minor Study sites: 17 to 20v6
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 17
    • Start date changed from estimate of Oct 18, 2022 to Jan 11, 2023
    • Eligibility criteria expanded, about 1 word
    v5
  3. Notable Start date: Jul 2022 to Oct 18, 2022v4 Show 9 more changesShow less
    • Primary endpoints: 1 to 2
    • Study sites: 0 to 1
    • Primary completion date: Jul 2027 to Oct 1, 2027
    • Study completion date: Dec 2027 to Dec 1, 2027
    • Interventions: First month DAPT (Drug), First month standard therapy (Drug) to 30-day DAPT (Drug), Guideline-directed therapy (Drug)
    • Eligibility criteria expanded, about 82 words
    • Secondary endpoints: 6 to 11
    • Study title shortened, about 7 words
    • Collaborators expanded, about 2 words
  4. Notable Primary completion date: Jul 2026 to Jul 2027v3 Show 7 more changesShow less
    • Start date: Jul 2020 to Jul 2022
    • Primary endpoints: 2 to 1
    • Enrollment target: 2500 to 2000
    • Study completion date: Dec 2026 to Dec 2027
    • Interventions: Dual therapy (Drug), Triple therapy (Drug) to First month DAPT (Drug), First month standard therapy (Drug)
    • Secondary endpoints: 9 to 6
    • Eligibility criteria shortened, about 4 words
  5. Minor Eligibility criteria expanded, about 2 wordsv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT04436978
Lead Sponsor St. Antonius Hospital
Collaborators: Daiichi Sankyo
Conditions
(from sponsor)
Acute Coronary Syndrome, Myocardial Infarction, Atrial Fibrillation, Atrial Flutter, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI, Bleeding, Stroke +3 more
Related terms Acute Coronary Syndrome, Atrial Fibrillation, Atrial Flutter, Coronary Artery Disease, Embolism, Hemorrhage, Myocardial Infarction, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction, Stroke, Thrombosis
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov