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Search / Trial NCT03785080

Non-warfarin Oral AntiCoagulant Resumption After Gastrointestinal Bleeding in Atrial Fibrillation Patients

Launched by CHINESE UNIVERSITY OF HONG KONG · Dec 20, 2018

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Gastrointestinal Bleeding Stroke Thromboembolism Atrial Fibrillation Noac

ClinConnect Summary

This clinical trial is studying the best time to safely restart a type of blood-thinning medication called non-warfarin oral anticoagulants (NOACs) in patients who have experienced upper gastrointestinal bleeding (GIB) and have atrial fibrillation (AF), a heart condition that increases the risk of stroke. Restarting NOACs too soon may cause more bleeding, while delaying their use can raise the chance of having a stroke. The trial aims to fill a gap in knowledge about when it is safe to restart these medications after a GIB.

To be eligible for this trial, participants must be at least 18 years old, have a history of atrial fibrillation, and have been taking a NOAC at the time of their GIB. They must also have experienced a specific type of bleeding that can be treated by a gastrointestinal specialist. Participants will be closely monitored throughout the study to determine the best approach to resuming their anticoagulant medication. It’s important for potential participants to know that certain conditions, like having a recent stroke or needing other treatments, may prevent them from joining the trial.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

About Chinese University Of Hong Kong

The Chinese University of Hong Kong (CUHK) is a prestigious research institution renowned for its commitment to advancing medical science and improving healthcare outcomes. As a clinical trial sponsor, CUHK leverages its extensive academic resources and interdisciplinary expertise to conduct innovative research that addresses critical health challenges. The university fosters collaboration among leading researchers, healthcare professionals, and industry partners, ensuring rigorous study design and implementation. CUHK is dedicated to upholding the highest ethical standards in clinical research, with a focus on translating findings into tangible benefits for patients and the broader community.

Locations

Singapore, , Singapore

Hong Kong, , Hong Kong

Blacktown, New South Wales, Australia

Patients applied

0 patients applied

Trial Officials

Joseph SUNG, MD

Principal Investigator

CUHK

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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