NCT06362343

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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

• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Rivaroxaban	Rivaroxaban

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-10-30
• Completion: 2027-01-30
• First posted: 2024-04-12
• Last updated: 2024-04-12

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study