Monitoring of NOAC Therapy: Standardizing Reference Intervals

NCT ID: NCT04611893

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-05

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemic Stroke Stroke, Acute Stroke Syndrome Ischemic

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

stroke ischemic stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. IP Yiu Ming Bonaventure

Specialist Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yiu Ming Bonaventure IP, MRCP

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yiu Ming Bonaventure IP, MRCP

Role: CONTACT

Phone: 852-35053856

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yiu Ming Bonaventure IP, MRCP

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Crec 2020.376

Identifier Type: -

Identifier Source: org_study_id