Monitoring and dosing guidance for anticoagulants in pulmonary embolism patients
The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics
This study is testing a new way to monitor and adjust blood-thinning medication for people with pulmonary embolism to see if it can improve their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06362343 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a population pharmacokinetic-pharmacodynamic (PK-PD) model for Direct Oral Anticoagulants (DOACs) in patients with pulmonary embolism. It will investigate the factors influencing the PK-PD of DOACs, including the correlation between genetic characteristics and clinical outcomes. The study will also explore the relationship between drug concentrations, coagulation indices, and clinical outcomes to establish effective monitoring and dosing strategies for DOACs.
Who should consider this trial
Good fit: Ideal candidates are adult patients diagnosed with acute symptomatic pulmonary embolism who are eligible for Xa factor inhibitors and have completed the acute phase of anticoagulation.
Not a fit: Patients with severe liver dysfunction, severe renal impairment, or contraindications for Xa factor inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized anticoagulant dosing, improving treatment outcomes for patients with pulmonary embolism.
How similar studies have performed: Other studies have shown promise in using pharmacogenomics and PK-PD modeling for anticoagulant therapy, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Juhong Shi, M.D — Peking Union Medical College Hospital
- Study coordinator: juhong Shi, M.D
- Email: shijh@pumch.cn
- Phone: +8613701178492
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.