Evidence map›Paper›PMID 36691239›Full record

ArticleBMJ open2022

Rationale and design of a prospective study evaluating population pharmacokinetics and pharmacodynamics of rivaroxaban in Chinese patients with non-valvular atrial fibrillation.

Xiao-Qin Liu, Yu-Fei Zhang, Hong-Yan Ding, Ming-Ming Yan, Ming-Kang Zhong, Chun-Lai Ma

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 30% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Xiao-Qin LiuDepartment of Pharmacy, Huashan Hospital Fudan University, Shanghai, China.ORCID 0000-0002-3615-3274
Yu-Fei ZhangDepartment of Pharmacy, Huashan Hospital Fudan University, Shanghai, China.
Hong-Yan DingDepartment of Neurology, Huashan Hospital Fudan University, Shanghai, China.
Ming-Ming YanDepartment of Pharmacy, Huashan Hospital Fudan University, Shanghai, China.
Ming-Kang ZhongDepartment of Pharmacy, Huashan Hospital Fudan University, Shanghai, China.
Chun-Lai MaDepartment of Pharmacy, Huashan Hospital Fudan University, Shanghai, China chunlaima@126.com.
Fudan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRivaroxaban is one of the most commonly used non-vitamin K antagonists for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Different individual exposures exist for Asian and non-Asian populations, and dose selection is different for Japanese and non-Japanese subjects. Few studies have investigated the pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in Chinese patients and provided a solid reference for dose selection and individualised therapy. METHODS AND ANALYSIS: This is a single-centre prospective study. Rivaroxaban-treated Chinese NVAF patients will be recruited according to predetermined inclusion criteria. Blood samples will be collected from both outpatients and inpatients with different sampling strategies at steady state. Rivaroxaban plasma concentration, factor Xa activity, prothrombin time and single-nucleotide polymorphisms of candidate genes will be evaluated. Follow-up will be conducted following 3 and 6 months after enrolment to collect information about the safety and efficacy outcomes. A nonlinear mixed-effects modelling strategy will be used to develop a population PK-PD model of rivaroxaban. ETHICS AND DISSEMINATION: The study has been approved by the Ethics Committee of Huashan Hospital, Fudan University (KY2020-016). The study findings will be submitted to peer-reviewed journals and shared with public health authorities. TRIAL REGISTRATION NUMBER: ChiCTR2100046685.

Indexed as

Atrial FibrillationStrokeAnticoagulantsEast Asian PeopleFactor Xa InhibitorsHumansInpatientsProspective StudiesRivaroxabanAnticoagulantsFactor Xa InhibitorsRivaroxabananticoagulationclinical pharmacologystroke medicine

Identifiers

PMID36691239
PMCPMC9171211
OpenAlexW4281727372

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.