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

Peking Union Medical College Hospital300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Pulmonary Embolism

Interventions

RivaroxabanDRUG

Rivaroxaban

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Bleeding events

Major bleeding events, clinical relatied non-major bleeding events and minor bleeding events

Time frame: Through the entire follow-up time, 3 months

Recurrent thromboembolic events