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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2027-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with pulmonary embolism and using direct oral anticoagulants

Rivaroxaban

Intervention Type DRUG

Rivaroxaban

Interventions

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Rivaroxaban

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No