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NCT04611893 Clinical Trial

Monitoring of NOAC Therapy: Standardizing Reference Intervals

Ischemic Stroke Clinical Trial

Official title:
Monitoring of NOAC Therapy: Standardizing Reference Intervals

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04611893
Other study ID # Crec 2020.376
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 5, 2020
Est. completion date August 31, 2024

Study information
Verified date January 2024
Source Chinese University of Hong Kong
Contact Yiu Ming Bonaventure IP, MRCP
Phone 852-35053856
Email iym984@ha.org.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 360
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Hong Kong Chinese University of Hong Kong Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Primary NOAC level in blood The NOAC level in blood before and after the medication One week after the recruitment
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