Observational studyClinical pharmacokinetics2026
Development and Clinical Application of a Real-World Population Pharmacokinetic Model of Rivaroxaban in Asian Patients with Atrial Fibrillation.
Observational study in Clinical pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05333666 (The Association Between Non-vitamin K Antagonist Oral Anticoagulant Concentration and Clinical Outcomes), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Association Between Non-vitamin K Antagonist Oral Anticoagulant Concentration and Clinical Outcomes (The Direct Oral AntiCoagulant Registry in Taiwan, DOACT)
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0 citing papers in PubMed.
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Corrections and comments
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Authors and funding
8 authors.
Funding
Abstract
backgroundRivaroxaban, a factor Xa inhibitor, is used to prevent stroke in patients of atrial fibrillation (AF). This study aimed to establish a population pharmacokinetic (PPK) model for rivaroxaban using real-world data, apply it to concentration prediction, and investigate the association between drug exposure and clinical outcomes.
methodsPatients with AF receiving rivaroxaban were enrolled from an observational cohort (2016-2023) to measure plasma concentrations. An independent cohort was randomly selected to validate the PPK model. Clinical outcomes of interest included stroke or systemic thromboembolism, and major bleeding.
resultsA total of 226 patients contributed to 452 rivaroxaban concentration measurements. Rivaroxaban pharmacokinetics were adequately described using a one-compartment model with first-order elimination. The estimated apparent clearance (CL/F) and the volume of distribution (V/F) were 6.13 L/h and 45.57 L, respectively. CL/F was significantly influenced by creatinine clearance and concomitant use of cytochrome 3A4 or P-glycoprotein inhibitors, whereas V/F was associated with lean body weight. External validation demonstrated a good predictive performance at the individual level. Patients with low trough concentrations tended to have an increased risk of systemic thromboembolism, whereas those with high trough concentrations tended to have a higher risk of major bleeding.
conclusionsIn an Asian population, rivaroxaban pharmacokinetics are influenced by renal function, lean body weight, and drug interactions. The developed PPK model facilitates the estimation of rivaroxaban concentrations at standardized timepoints from random samples. This provides a practical tool for standardized exposure assessment and the identification of patients at risk for adverse clinical outcomes. REGISTRATION: ClinicalTrials.gov identifier no. NCT05333666.
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