Trial reportThrombosis and haemostasis2008
Population pharmacokinetics and pharmacodynamics of once- and twice-daily rivaroxaban for the prevention of venous thromboembolism in patients undergoing total hip replacement.
Trial report in Thrombosis and haemostasis, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05658042 (Therapeutic Drug Monitoring Combined With Quantitative Pharmacology for Dose Optimization of Rivaroxaban in Combination With Rifampicin in Patients With Periprosthetic Joint Infection), which is not on this map. Cited by 100 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Therapeutic Drug Monitoring Combined With Quantitative Pharmacology for Dose Optimization of Rivaroxaban in Combination With Rifampicin in Patients With Periprosthetic Joint Infection
Who cites it
100 citing papers in PubMed, 5 syntheses or guidelines pooled it, 271 citations in OpenAlex.
- Direct factor Xa inhibitors versus low molecular weight heparins or vitamin K antagonists for prevention of venous thromboembolism in elective primary hip or knee replacement or hip fracture repair.The Cochrane database of systematic reviews · 2025Pooled it
- The non-vitamin K antagonist oral anticoagulants (NOACs) and extremes of body weight-a systematic literature review.Clinical research in cardiology : official journal of the German Cardiac Society · 2017Pooled it
- Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants: A Systematic Review.Chest · 2017Pooled it
- Use of the direct oral anticoagulants in obese patients: guidance from the SSC of the ISTH.Journal of thrombosis and haemostasis : JTH · 2016Guideline
- Pooled it
- Platelet-rich fibrin ensures hemostasis after single-tooth removal under factor Xa inhibitors - a clinical prospective randomized split-mouth study.Clinical oral investigations · 2023Trial
- Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in the prevention of venous thromboembolism.Journal of thrombosis and thrombolysis · 2020Trial
- Laboratory monitoring of rivaroxaban in Chinese patients with deep venous thrombosis: a preliminary study.BMC pharmacology & toxicology · 2020Trial
- Effect of Activated Charcoal on Rivaroxaban Complex Absorption.Clinical pharmacokinetics · 2017Trial
- Clinical evaluation of laboratory methods to monitor exposure of rivaroxaban at trough and peak in patients with atrial fibrillation.European journal of clinical pharmacology · 2016Trial
- Standardized use of novel oral anticoagulants plasma level thresholds in a new thrombolysis decision making protocol.Journal of thrombosis and thrombolysis · 2016Trial
- Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban.Clinical pharmacokinetics · 2014Trial
- Population pharmacokinetics and pharmacodynamics of rivaroxaban in patients with acute coronary syndromes.British journal of clinical pharmacology · 2012Trial
- Rivaroxaban: population pharmacokinetic analyses in patients treated for acute deep-vein thrombosis and exposure simulations in patients with atrial fibrillation treated for stroke prevention.Clinical pharmacokinetics · 2011Trial
- Rivaroxaban in Chinese children with giant coronary artery aneurysms after Kawasaki disease.Research and practice in thrombosis and haemostasis · 2025Article
- Population pharmacokinetic analysis of rivaroxaban in healthy volunteers and patients with radiofrequency ablation of non-valvular atrial fibrillation in China.Frontiers in pharmacology · 2025Article
- Handling delayed or missed direct oral anticoagulant doses: model-informed individual remedial dosing.Blood advances · 2024Article
- Population pharmacokinetics of rivaroxaban in Chinese deep vein thrombosis patients and the exposure simulation for dosing recommendation.Naunyn-Schmiedeberg's archives of pharmacology · 2024Article
- Efficacy and Safety of Different Doses of Rivaroxaban and Risk Factors for Bleeding in Elderly Patients with Venous Thromboembolism: A Real-World, Multicenter, Observational, Cohort Study.Advances in therapy · 2024Observational
- Generic Methods for Simultaneous Analysis of Four Direct Oral Anticoagulants in Human Plasma and Urine by Ultra-High Performance Liquid Chromatography-Tandem Mass Spectrometry.Molecules (Basel, Switzerland) · 2023Article
40 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Rivaroxaban (Xarelto) is an oral, direct factor Xa inhibitor in advanced clinical development for the prevention and treatment of thromboembolic disorders. The aim was to compare the population pharmacokinetics (PK) and pharmacodynamics (PD) of twice-daily (bid) and once-daily (od) rivaroxaban in patients undergoing total hip replacement (THR). Blood samples were collected from patients enrolled in two phase IIb, dose-ranging studies undertaken to investigate rivaroxaban for thromboprophylaxis after THR. A sparse sampling technique was used and the samples were pooled for PK and PD analysis, which used non-linear mixed effect modelling. Rivaroxaban PK (samples from 758 patients) were well described by an oral, one-compartment model; age and renal function influenced clearance, and body surface area affected volume of distribution. When comparing the same total daily doses, maximum plasma concentrations of rivaroxaban were higher and minimum plasma concentrations were lower with od dosing, compared with bid dosing; however, the 90% intervals overlapped. The area under the plasma concentration-time curve was 18-30% higher in the od than in the bid study. Prothrombin time in seconds (samples from 1181 patients) correlated with rivaroxaban plasma concentrations in a linear fashion in both studies. In conclusion, the PK and PD of rivaroxaban were predictable when given either bid or od. These findings, along with the suggested efficacy and safety of rivaroxaban in the phase II studies, relative to enoxaparin, supported the selection of a convenient, once-daily 10 mg rivaroxaban dose for investigation in phase III studies.
Indexed as
Identifiers
18766262W2060578439What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.