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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Not yet recruiting
    • National Taiwan University Hospital
    • Contact: Shin Yi Lin, MS; Email: hsin924@ntuh.gov.tw
  • Please Select
    • Taipei, Please Select, Taiwan, 100
      • Recruiting
      • National Taiwan University Hospital
      • Contact: Shin Yi Lin, MS; Phone Number: 63699 +886223123456; Email: 102067@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients under NOAC therapy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Age over 20 years and under non-vitamin K antagonist oral anticoagulant therapy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with ischemic stroke, transient ischemic attack or systemic thromboembolism.	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major or life-threatening bleeding	The severity of bleeding is classified by using the PLATO criteria	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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: April 17, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 202201014RINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No