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Monitoring of NOAC Therapy: Standardizing Reference Intervals

Monitoring of NOAC Therapy: Standardizing Reference Intervals

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04611893
Enrollment
308
Registered
2020-11-02
Start date
2020-11-05
Completion date
2025-06-30
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic, Ischemic Stroke, Stroke, Acute, Stroke Syndrome

Keywords

stroke, ischemic stroke

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.

Interventions

None listed

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
NOAC level in bloodOne week after the recruitmentThe NOAC level in blood before and after the medication

Countries

Hong Kong

Contacts

PRINCIPAL_INVESTIGATORYiu Ming Bonaventure IP, MRCP

Chinese University of Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026