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

NCT06362343 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-04-12

No results posted yet for this 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.

Conditions

Interventions

DRUG

Rivaroxaban

Rivaroxaban

Sponsors & Collaborators

  • Ruijin Hospital

    collaborator OTHER

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • China-Japan Friendship Hospital

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Juhong Shi, M.D · Peking Union Medical College Hospital

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-10-30
Completion
2027-01-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06362343 on ClinicalTrials.gov