Evaluating DOAC levels in Chinese patients with atrial fibrillation
Direct Oral Anticoagulant Levels in Chinese Patients With Atrial Fibrillation - A Real- World Pharmacokinetic Study
This study is testing how stopping blood-thinning medication for a short time affects Chinese patients with atrial fibrillation to see if it's safe for them during medical procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 427 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05378035 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the levels of direct oral anticoagulants (DOACs) in Chinese patients with non-valvular atrial fibrillation who require temporary discontinuation of their medication for elective medical procedures. The study will measure DOAC levels at various time points after stopping the medication to determine if a shorter interruption period is safe and effective for this population. By focusing on ethnic-specific pharmacokinetics, the study seeks to provide insights that could optimize anticoagulation management in Chinese patients. Participants will be recruited from the Prince of Wales Hospital and will undergo blood tests to evaluate their DOAC levels.
Who should consider this trial
Good fit: Ideal candidates are Chinese patients aged 18-80 with non-valvular atrial fibrillation who have been on DOACs for at least six months and require elective procedures necessitating medication interruption.
Not a fit: Patients who have experienced thromboembolism or major bleeding during DOAC use, or those with significant renal impairment, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored anticoagulation management for Chinese patients, potentially reducing the risk of complications during medical procedures.
How similar studies have performed: While there is a growing body of research on DOACs, this study's focus on ethnic-specific pharmacokinetics in a Chinese population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hong Kong
- Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Bonaventure Yiu Ming IP, MB ChB — Chinese University of Hong Kong
- Study coordinator: Bonaventure Yiu Ming IP, MB ChB
- Email: bonaventureip@cuhk.edu.hk
- Phone: 852-28902002
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.