Monitoring of NOAC Therapy: Standardizing Reference Intervals

Recruiting

• Conditions: Stroke Syndrome; Ischemic; Ischemic Stroke; Stroke, Acute

• Registration Number: NCT04611893
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This study is aimed to establish reference intervals of NOAC (dabigatran, apixaban and rivaroxaban) in ethnic Chinese patients.

Detailed Description

360 patients who are on dabigatran, apixaban and rivaroxaban based on the above inclusion and exclusion criteria will be recruited. After the informed consent, the patient will be needed for blood taking before and 2 hours after the medication (NOAC). The patient's demographic data and medical history will also be retreived from Central Medical Syetem too.

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-02
• Study Start: 2020-11-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NOAC level in blood	One week after the recruitment	The NOAC level in blood before and after the medication

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong