Monitoring of NOAC Therapy: Standardizing Reference Intervals

NCT04611893 | Completed

• 1 other identifier: Crec 2020.376
• Study Type: observational
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Stroke; Stroke, Acute; Stroke Syndrome; Ischemic

Keywords

stroke; ischemic stroke

Outcome Measures

Primary Outcomes (1)

• NOAC level in blood

  The NOAC level in blood before and after the medication

  One week after the recruitment

Study Arms (1)

Ischemic stroke patient

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Ethnic Chinese ONLY
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood tests for haemoglobin level, platelet count, activated partial thromboplastin time (aPTT), prothrombin time (PT), international normalized ratio (INR), creatinine clearance (by Cockcroft-Gault formula), alanine aminotransferase, alkaline phosphatase, bilirubin, modified thrombin time (dabigatran users), factor-Xa assay (for apixaban, rivaroxaban users) will be performed at the same time as blood taking for NOAC levels.

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yiu Ming Bonaventure IP, MRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Resident

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 2, 2020
• Study Start: November 5, 2020
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)