NCT05333666 The Association Between Non-vitamin K Antagonist Oral Anticoagulant Concentration and Clinical Outcomes.
| NCT ID | NCT05333666 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2022-03-21 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2022-03-21 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Introduction: Non-vitamin K antagonist oral anticoagulants (NOAC) is the first line therapy to prevent ischemic stroke or systemic thromboembolism among atrial fibrillation (AF) patients. Since 2016, our study team enrolled patients under NOAC therapy in National Taiwan University Hospital, and measured their NOAC concentration to develop a cohort of NOAC treatment and NOAC concentration. Study purpose: Based on the cohort of NOAC therapy, we aim to investigate factors driving high or low NOAC concentration, and link NOAC concentration to clinical outcomes. Methods: For all the participants in the cohort, we will retrieve their basic characteristic, concurrent medications, laboratory tests and clinical outcomes such as ischemic stroke, systemic thromboembolism, intracranial hemorrhage, major bleeding and death from the electronic medical records. The NOAC concentration will be compared to the expected range reported in clinical trials to define higher, within or lower than expected range. Univariate logistic regression will be used first, followed by multivariate logistic regression to investigate factors associated with high or low NOAC concentration. The relationship between NOAC concentration and clinical outcomes will be investigated by using the Cox proportional hazard model.
Eligibility Criteria
Inclusion Criteria: * Age more than 20 years. * Under NOAC therapy. Exclusion Criteria: * Failed to provide at least one blood sample for NOAC concentration measurement. * Declined to provide informed consent
Frequently Asked Questions
Who can join the NCT05333666 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05333666 currently recruiting?
Yes, NCT05333666 is actively recruiting participants. Visit ClinicalTrials.gov or contact National Taiwan University Hospital to inquire about joining.
Where is the NCT05333666 trial being conducted?
This trial is being conducted at Taipei, Taiwan, Taipei, Taiwan.
Who is sponsoring the NCT05333666 clinical trial?
NCT05333666 is sponsored by National Taiwan University Hospital. The trial plans to enroll 1,500 participants.
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