The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06362343

Enrollment

300

Registered

2024-04-12

Start date

2024-01-01

Completion date

2027-01-30

Last updated

2024-04-12

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

Conditions

Pulmonary Embolism

Brief summary

1. Integrate pharmacokinetic-pharmacodynamic (PK-PD) modeling and pharmacogenomics techniques to develop a population PK-PD model, aiming to explore monitoring and dose guidance schemes for Direct Oral Anticoagulants (DOACs). 2. Investigate the factors influencing PK-PD of DOACs in the pulmonary embolism population, clarifying the correlation between genotype characteristics and clinical outcomes. 3. Explore the correlation between drug concentrations, coagulation indices, and clinical outcomes of DOACs, defining the indications for DOACs testing and the overall monitoring process.

Interventions

DRUGRivaroxaban

Rivaroxaban

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

* Adult patients with acute symptomatic pulmonary embolism objectively diagnosed by imaging (with or without deep vein thrombosis) who have completed anticoagulation for the acute phase and have entered the maintenance phase of anticoagulation * Expected lifespan greater than 3 months * Eligible for the use of Xa factor inhibitors; * Agreement to participate in the study, signing of informed consent, and commitment to regular follow-up.

Exclusion criteria

* Moderate or severe liver dysfunction (Child-Pugh grade B or C); * Severe renal impairment (CrCl \< 15 ml/min); * Pregnant or breastfeeding women; * Tendency for spontaneous bleeding, such as coagulopathy or thrombocytopenia (PLT \< 20×10\^9/L); * Contraindications for the use of other Xa factor inhibitors; * Patients diagnosed with hereditary thrombophilia and antiphospholipid syndrome.

Design outcomes

Primary

Measure	Time frame	Description
Bleeding events	Through the entire follow-up time, 3 months	Major bleeding events, clinical relatied non-major bleeding events and minor bleeding events
Recurrent thromboembolic events	Through the entire follow-up time, 3 months	Recurrent thromboembolic events

Countries

China

Contacts

Primary Contactjuhong Shi, M.D

shijh@pumch.cn+8613701178492

Backup Contactyiyao Li, M.D

yiyo927@163.com18510797366

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026