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Search / Trial NCT05378035

DOAC in Chinese Patients With Atrial Fibrillation

Launched by CHINESE UNIVERSITY OF HONG KONG · May 12, 2022

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how direct oral anticoagulants (DOACs) work in Chinese patients with non-valvular atrial fibrillation (NVAF). Atrial fibrillation is a heart condition that increases the risk of stroke, and DOACs are medications used to help prevent this. The trial aims to gather information about how these medications behave in different ethnic groups, particularly since some studies suggest that the effects may differ between Caucasian and Asian populations. By studying these differences, researchers hope to improve the care for patients who need to temporarily stop taking their anticoagulants for medical procedures.

To participate in this trial, you need to be a Chinese adult aged between 18 and 80 who has been on one of the DOAC medications (apixaban, dabigatran, edoxaban, or rivaroxaban) for at least six months. You must also be planning to undergo an elective medical procedure that requires stopping your medication for 48 hours. If you qualify, you can expect to undergo assessments aimed at measuring how your body processes these medications, which will help inform safer and more effective treatment strategies for patients like you in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Chinese nonvalvular atrial fibrillation (NVAF) patients on apixaban, dabigatran, edoxaban, or rivaroxaban for 6 months or more.
  • Patients aged 18-80 years old.
  • Patients who are able to provide an informed consent.
  • Patients who are indicated for elective medical procedures that require interruption of direct oral anticoagulants (DOAC) for 48 hours.
  • Exclusion Criteria:
  • Patients who developed thromboembolism (e.g. ischemic stroke, ischemic bowel, etc.) or major systemic bleeding (e.g. intracerebral haemorrhage, gastrointestinal bleeding) during DOAC usage.
  • Patients with creatinine clearance by Cockroft-Gault formula ≤ 30 mL/min.
  • Patients with inappropriate DOAC dosages with respect to age, body weight, and creatinine clearance.
  • Patients who receive DOAC with indications other than NVAF, such as history of mitral stenosis, metallic heart valve, thrombophilia, venous thromboembolism, etc.
  • Patients with conditions that alter haemostasis besides DOAC use, such as essential thrombocytosis, hepatic congestion, hepatic failure with coagulopathy, etc.

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

Hong Kong, , Hong Kong

Patients applied

0 patients applied

Trial Officials

Bonaventure Yiu Ming IP, MB ChB

Principal Investigator

Chinese University of Hong Kong

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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