Ignite Creation Date:
2024-05-06 @ 2:48 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04436978
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2020-06-16
Brief Title:
What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI
Sponsor:
St Antonius Hospital
Organization:
St Antonius Hospital
Study Overview
Official Title:
What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Having Acute Coronary Syndrome or Undergoing Percutaneous Coronary Intervention
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WOEST-3
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 ie 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 ie 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-001298-30 | EUDRACT_NUMBER | None | None |