Using rivaroxaban for elderly patients with blood clots in China
The Exploratory Study on Clinical Rational Use of Rivaroxaban Dosing in Elderly Chinese Population
This study is testing how to adjust the dose of rivaroxaban for older patients in China with blood clots to make sure it's safe and effective for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06194617 on ClinicalTrials.gov |
What this trial studies
This observational study aims to optimize dosing regimens of rivaroxaban, a direct oral anticoagulant, for elderly patients in China who have been diagnosed with pulmonary embolism or venous thromboembolism. It focuses on understanding the pharmacokinetics and pharmacodynamics of rivaroxaban in this population, particularly in those with varying degrees of renal and liver function. By evaluating lab indicators and patient responses, the study seeks to balance the risks of bleeding and recurrence of blood clots. The findings could help establish more tailored anticoagulation strategies for high-risk elderly patients.
Who should consider this trial
Good fit: Ideal candidates are elderly adults diagnosed with acute symptomatic pulmonary embolism who have completed initial anticoagulation treatment.
Not a fit: Patients with severe renal or hepatic impairment, or those with contraindications to rivaroxaban, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective anticoagulation management for elderly patients at risk of venous thromboembolism.
How similar studies have performed: While there have been studies on rivaroxaban, this specific focus on elderly patients in China and their unique pharmacokinetic profiles is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) Adult patients with objectively diagnosed acute symptomatic pulmonary embolism (with or without concurrent deep vein thrombosis) by imaging, who have completed acute anticoagulation and entered the anticoagulation maintenance phase; (2) Life expectancy greater than 3 months; (3) Meeting the indications for Xa factor inhibitor use; (4) Willingness to participate in this study, sign the informed consent form, and adhere to regular follow-ups. Exclusion Criteria: * (1) Moderate or severe hepatic impairment (Child-Pugh Class B or C); (2) Severe renal impairment (CrCl \< 15ml/min); (3) Pregnant or breastfeeding women; (4) Spontaneous bleeding tendencies, such as coagulation disorders or low platelet count (PLT \< 20×10\^9/L); (5) Contraindications to other Xa factor inhibitors' usage; (6) 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
- Study coordinator: juhong Shi, M.D
- Email: shijh@pumch.cn
- Phone: +8513701178492
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.