NCT06362343 The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics
| NCT ID | NCT06362343 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Pulmonary Embolism |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-01-01 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Juhong Shi, M.D
PRINCIPAL INVESTIGATOR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT06362343 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Pulmonary Embolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06362343 currently recruiting?
Yes, NCT06362343 is actively recruiting participants. Contact the research team at shijh@pumch.cn for enrollment information.
Where is the NCT06362343 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06362343 clinical trial?
NCT06362343 is sponsored by Peking Union Medical College Hospital. The principal investigator is Juhong Shi, M.D at Peking Union Medical College Hospital. The trial plans to enroll 300 participants.