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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital, Taipei, Please Select, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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.

Primary outcomes

Number of patients with ischemic stroke, transient ischemic attack or systemic thromboembolism.

Time frame: From the date of study enrollment to end of NOAC exposure, death, occurrence of aforementioned outcome (ischemic stroke, transient ischemic attack or systemic thromboembolism) or end of the study, whichever comes first, assessed up to 100 months.

ischemic stroke, defined as an episode of neurological dysfunction caused by focal cerebral infarction. Transient ischemic attack is defined as a transient episode of neurological dysfunction caused by focal brain ischemia without acute infarction. The diagnose tool included clinical and radiological diagnosis included CT and MRI. Systemic thromboembolism includes myocardial infarction, venous thromboembolism, coronary artery disease or peripheral arterial occlusive disease.

Secondary outcomes

Major or life-threatening bleeding

Time frame: From the date of study enrollment to end of NOAC exposure, death, occurrence of major bleeding or life-threatening bleeding classified by using the PLATO criteria or end of the study, whichever comes first, assessed up to 100 months

The severity of bleeding is classified by using the PLATO criteria

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

The Association Between Non-vitamin K Antagonist Oral Anticoagulant Concentration and Clinical Outcomes (The Direct Oral AntiCoagulant Registry in Taiwan, DOACT)

Important dates

Study start: 2022
Primary completion: 2028
Study completion: 2028
First posted: Apr 19, 2022
Registry last updated: Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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