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

Recruiting

• Conditions: Pulmonary Embolism
• Interventions: Drug: Rivaroxaban

• Registration Number: NCT06362343
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12
• Primary Completion: 2026-10-30
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with pulmonary embolism and using direct oral anticoagulants	Rivaroxaban	Patients with pulmonary embolism and using direct oral anticoagulants

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China