The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rivaroxaban.
- Who it may be relevant to
- Registry conditions: Pulmonary Embolism. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Drug Rivaroxaban
Rivaroxaban
Primary outcome measures
- Bleeding events [Time frame: Through the entire follow-up time, 3 months]
- Recurrent thromboembolic events [Time frame: Through the entire follow-up time, 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT06362343 · PUMCH-Rivaroxaban-Monitoring