Actively Recruiting
Direct Oral Anticoagulant Levels in Chinese Patients With Atrial Fibrillation - A Real- World Pharmacokinetic Study
Led by Chinese University of Hong Kong · Updated on 2025-01-29
427
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the levels of direct oral anticoagulants (DOACs) in Chinese patients with non-valvular atrial fibrillation (NVAF) who require temporary discontinuation of these medications before elective medical procedures. The study aims to understand ethnic-specific DOAC pharmacokinetics and pharmacogenomics, especially since current guidelines based on Western populations may not apply well to Asian patients. The research focuses on drugs apixaban, dabigatran, edoxaban, and rivaroxaban, which have been widely prescribed for stroke prevention in NVAF. Participants will have their DOAC levels measured at peak, trough, and at 24 and 48 hours after stopping the medication before procedures like colonoscopy or cardiac catheterization. Blood samples will be collected for coagulation assays, liquid chromatography-mass spectrometry, and genetic analysis to study drug metabolism. Additional data on demographics, clinical status, comorbidities, and concurrent medications will be recorded. The study includes educating patients on DOAC management and close monitoring during the interruption period. During the study, participants will undergo physical measurements, blood tests, and follow-up assessments for bleeding or ischemic events up to 30 days after their procedures. The research team will monitor neurological status and ensure patient safety with immediate assessment by stroke specialists if needed. The goal is to inform better DOAC use and periprocedural care for Asian populations, potentially improving stroke treatment and reducing complications. The study is expected to continue through 2027.
CONDITIONS
Brief Title
DOAC in Chinese Patients With Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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 40 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and informed consent
Duration - Approximately 3 days around the elective procedure
Participants undergo blood tests to measure DOAC levels at peak, trough, 24, and 48 hours after discontinuation for elective medical procedures. Baseline demographics, clinical assessments, medical comorbidities, blood parameters, and concurrent medications are also recorded.
1 baseline visit and up to 4 blood sampling visits within 48 hours after DOAC interruption
Duration - 30 days after the procedure
Participants are monitored for neurological and hemodynamic stability after DOAC resumption, with a follow-up appointment to evaluate procedural outcomes and any bleeding or ischemic events 30 days after the procedure.
1 follow-up visit approximately 30 days post-procedure
Trial Site Locations
Total: 1 location
1
Chinese University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
B
Bonaventure Yiu Ming IP, MB ChB
T
Thomas Wai Hong LEUNG, MB ChB
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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