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

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06362343
• Other study ID #: PUMCH-Rivaroxaban-Monitoring
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: January 30, 2027

Study information

• Verified date: April 2024
• Source: Peking Union Medical College Hospital
• Contact: juhong Shi, M.D
• Phone: +8613701178492
• Email: shijh[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 30, 2027
• Est. primary completion date: October 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Drug:
• Rivaroxaban
Rivaroxaban

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	China-Japan Friendship Hospital, Ruijin Hospital, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

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