Population pharmacokinetic/pharmacodynamic analysis of rivaroxaban in non-valvular atrial fibrillation patients

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100046685

Enrollment

Unknown

Registered

2021-05-26

Start date

2021-06-01

Completion date

Unknown

Last updated

2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-valvular atrial fibrillation

Interventions

inpatients with rivaroxaban treatment group:Nil

outpatients with rivaroxaban group:Nil

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Han nationality, aged >= 18 years; 2. Diagnosed with non-valvular atrial fibrillation and prescribed rivaroxaban; 3. With complete medical history, understand and sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant patients; 2. History of malignant tumor; 3. Severe hepatic and renal insufficiency (Child-Pugh grade C; CrCl<15mL·min^-1); 4. Severe bradycardia (sick sinus syndrome, high-grade atrioventricular block, etc); 5. Patients with abnormal coagulation function or disease predisposing to bleeding such as thrombocytopenia and other causes; 6. Patients participating in clinical trials of other drugs at the same time; 7. Patients who are not cooperative or nonadherent to anticoagulation.

Design outcomes

Primary

Measure	Time frame
rivaroxaban plasma concentration;anti-FXa assay;CYP3A4 genotype;ABCB1 genotype;BCRP genotype;	—

Secondary

Measure	Time frame
Biochemical indices;Clinical efficacy/outcomes;	—

Countries

China

Contacts

Public ContactMa Chunlai

Huashan Hospital, Fudan University

chunlaima@126.com+86 13764634191

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026