Clinical trial NCT05333666: The Association Between Non-vitamin K Antagonist Oral Anticoagulant Concentration and Clinical Outcomes.
Official title: The Association Between Non-vitamin K Antagonist Oral Anticoagulant Concentration and Clinical Outcomes (The Direct Oral AntiCoagulant Registry in Taiwan, DOACT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under NOAC therapy.

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

Primary outcomes:
measure: Number of patients with ischemic stroke, transient ischemic attack or systemic thromboembolism.
timeFrame: 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 outcomes:
measure: Major or life-threatening bleeding
timeFrame: 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
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Please Select
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: