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The Association Between Non-vitamin K Antagonist Oral Anticoagulant Concentration and Clinical Outcomes.

NCT05333666 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2025-03-26

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Data collection

This investigation aims to collect and analyze the data from a cohort. During the cohort development, all participants received venous puncturing for NOAC concentration measurement. However, the standard treatment protocol was not changed after study enrollment. In this retrospective cohort study, we only collect data from the cohort without further intervention to the participants.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05333666 on ClinicalTrials.gov