Monitoring of NOAC Therapy: Standardizing Reference Intervals

The Chinese University of Hong Kong

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT04611893

Crec 2020.376

Details and patient eligibility

About

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

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

360 participants in 1 patient group

Ischemic stroke patient

Description:

Ischemic stroke patients who are on dabigatran, apixaban and rivaroxaban based on the above inclusion and exclusion criteria will be recruited from the Prince of Wales Hospital, either in-patient or out-patient clinic