Status:
RECRUITING
DOAC in Chinese Patients With Atrial Fibrillation
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
18-80 years
Brief Summary
Direct oral anticoagulants (DOACs) have emerged as safe and efficacious ischemic stroke prophylaxis for non-valvular atrial fibrillation (NVAF). All four DOACs - apixaban, dabigatran, edoxaban, and ri...
Detailed Description
The investigators aim to determine the DOAC levels at peak, trough, 24, and 48 hours after temporary discontinuation of apixaban, dabigatran, edoxaban, or rivaroxaban before elective interventional pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 28 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
427 Patients enrolled
Trial Details
Trial ID
NCT05378035
Start Date
September 28 2022
End Date
December 31 2027
Last Update
January 29 2025
Active Locations (1)
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1
Chinese University of Hong Kong
Hong Kong, Hong Kong