Monitoring of NOAC Therapy: Standardizing Reference Intervals

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    360
  • sponsor
    Chinese University of Hong Kong
Updated on 26 January 2021

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.

Details
Condition Cerebrovascular accident, Ischemic Stroke, Ischemic, Stroke, acute stroke, cerebrovascular accidents, strokes, cerebral
Clinical Study IdentifierNCT04611893
SponsorChinese University of Hong Kong
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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