Status:
UNKNOWN
Non-warfarin Oral AntiCoagulant Resumption After Gastrointestinal Bleeding in Atrial Fibrillation Patients
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Upper Gastrointestinal Bleeding
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Current clinical society guidelines and statements are non-specific and relatively open-ended regarding the optimal timing to restart non-warfarin oral anticoagulant (NOAC) after gastrointestinal blee...
Detailed Description
The effectiveness and relative safety of NOACs have been demonstrated in large international studies where reductions in the incidence of stroke in patients with AF have been reported. However, the be...
Eligibility Criteria
Inclusion
- Age ≥18 years
- History of AF
- Taking any kind of NOAC at the time of index acute GIB
- Acute upper GIB (non-variceal bleeding lesions accounting for the GIB) with or without endoscopic treatment confirmed endoscopic haemostasis verified by GI specialist
- Patient or next-of-kin able to provide informed consent
Exclusion
- Concomitant stroke (including TIA) at the time of index GIB
- Requiring bridging IV heparin therapy
- Portal hypertension
- Known bleeding diathesis
- Other conditions precluding use of NOAC at the time of randomisation
- Pregnancy
- Tumour bleeding
- Antidote administration to reverse anticoagulation effect of NOACs
Key Trial Info
Start Date :
March 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
552 Patients enrolled
Trial Details
Trial ID
NCT03785080
Start Date
March 11 2019
End Date
December 30 2025
Last Update
May 5 2020
Active Locations (3)
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1
Blacktown Hospital
Blacktown, New South Wales, Australia
2
Endoscopy Center, Prince of Wales Hospital
Hong Kong, Hong Kong
3
National University Hospital
Singapore, Singapore