Monitoring of NOAC Therapy: Standardizing Reference Intervals

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemia Ischemic Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Stroke Syndrome Stroke, Acute Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Ethnic Chinese ONLY
18 years old or above
Non-valvular atrial fibrillation
Duration of NOAC use at least 3 months
No changes in NOAC dosage or type within 3 months
Creatinine Clearance (by Cockcroft-Gault formula) >/=30mL/min

Exclusion criteria

Valvular atrial fibrillation or no atrial fibrillation
Recent haemorrhage or ischemia within 1 year
Active liver disease
Abnormal baseline clotting profile
Abnormal baseline thrombocytopenia or thrombocytosis
Thromboembolic tendency other than atrial fibrillation (e.g. antiphospholipid syndrome, protein C, S, anti-thrombin III deficiency)
Non-compliant patients, defined as missing any doses of NOAC in recent 1 month
Anticoagulation for disorders other than AF
Pregnancy

Treatment and study plan

Primary outcomes

NOAC level in blood

Time frame: One week after the recruitment

The NOAC level in blood before and after the medication

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2025
First posted: Nov 2, 2020
Registry last updated: Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed