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

Recruitingn/aAges 18 Years - 120 YearsAllPeking Union Medical College Hospital
NCT06362343 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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.
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What it tests

  • Rivaroxaban
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Where

1 site
Peking Union Medical College Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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