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Clinical Trials in China / NCT06362343
Recruiting Observational

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

NCT06362343 · tracked via the Priya Life Science China tracker
Sponsor
Peking Union Medical College Hospital
Phase
Observational
Started
2024-01-01
Last updated
2024-04-12

Condition(s) studied

Pulmonary Embolism

Investigational drug(s) / intervention(s)

Rivaroxaban

Rivaroxaban: Rivaroxaban

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
120 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing Beijing Municipality Recruiting

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06362343 on ClinicalTrials.gov ↗ ← All trials in China