Establishing reference intervals for NOAC therapy in ethnic Chinese patients
Monitoring of NOAC Therapy: Standardizing Reference Intervals
This study is trying to find the right blood test levels for certain blood thinners in ethnic Chinese patients with atrial fibrillation to help ensure they are getting the best treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT04611893 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish reference intervals for non-vitamin K antagonist oral anticoagulants (NOACs) such as dabigatran, apixaban, and rivaroxaban in ethnic Chinese patients. A total of 360 patients aged 18 and above with non-valvular atrial fibrillation who have been on NOAC therapy for at least three months will be recruited. Blood samples will be collected before and two hours after medication administration, and demographic and medical history data will be retrieved from the Central Medical System. The study seeks to standardize the monitoring of NOAC therapy specifically for this ethnic group.
Who should consider this trial
Good fit: Ideal candidates for this study are ethnic Chinese patients aged 18 and older with non-valvular atrial fibrillation who have been on NOAC therapy for at least three months.
Not a fit: Patients with valvular atrial fibrillation, recent hemorrhage or ischemia, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate monitoring and management of NOAC therapy in ethnic Chinese patients, potentially reducing the risk of stroke and other complications.
How similar studies have performed: While there may be studies on NOACs in other populations, this specific focus on ethnic Chinese patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ethnic Chinese ONLY 2. 18 years old or above 3. Non-valvular atrial fibrillation 4. Duration of NOAC use at least 3 months 5. No changes in NOAC dosage or type within 3 months 6. Creatinine Clearance (by Cockcroft-Gault formula) \>/=30mL/min Exclusion Criteria: 1. Valvular atrial fibrillation or no atrial fibrillation 2. Recent haemorrhage or ischemia within 1 year 3. Active liver disease 4. Abnormal baseline clotting profile 5. Abnormal baseline thrombocytopenia or thrombocytosis 6. Thromboembolic tendency other than atrial fibrillation (e.g. antiphospholipid syndrome, protein C, S, anti-thrombin III deficiency) 7. Non-compliant patients, defined as missing any doses of NOAC in recent 1 month 8. Anticoagulation for disorders other than AF 9. Pregnancy
Where this trial is running
Hong Kong
- Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Yiu Ming Bonaventure IP, MRCP — Chinese University of Hong Kong
- Study coordinator: Yiu Ming Bonaventure IP, MRCP
- Email: iym984@ha.org.hk
- Phone: 852-35053856
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.