Evaluating DOAC levels in Chinese patients with atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.