Actively Recruiting
The Exploratory Study on Clinical Rational Use of Rivaroxaban Dosing in Elderly Chinese Population
Led by Peking Union Medical College Hospital · Updated on 2024-01-08
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring how to optimize the dosing of rivaroxaban, a blood thinner used to treat pulmonary embolism and venous thromboembolism, in elderly Chinese patients. This research addresses uncertainties in dosing for older adults, especially those with multiple medications and declining kidney and liver function, to better balance the risks of bleeding and clot recurrence. The study aims to find appropriate laboratory indicators to monitor rivaroxaban's anticoagulant effects in this population. The study observes patients who have been diagnosed with acute symptomatic pulmonary embolism and are using direct oral anticoagulants like rivaroxaban. Participants take the medication as prescribed by their doctors, with doses adjusted based on clinical judgment. The study focuses on elderly patients during their anticoagulation maintenance phase. It monitors the drug's pharmacokinetic and pharmacodynamic properties to guide safe and effective dosing. During the study, participants will be regularly followed for about one year to track the recurrence of blood clots, fatal or non-fatal pulmonary embolism, and bleeding events categorized by established medical guidelines. Researchers will collect clinical data and lab tests to assess the drug's effects and safety. The study also observes patients' overall health status and medication use to provide a comprehensive understanding of rivaroxaban dosing in high-risk elderly patients.
CONDITIONS
Brief Title
Rivaroxaban in Elderly Chinese Venous Thromboembolism Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with acute symptomatic pulmonary embolism confirmed by imaging, with or without deep vein thrombosis, who have completed acute anticoagulation and are in the maintenance phase
- Life expectancy longer than 3 months
- Meet indications for Xa factor inhibitor use
- Willing to participate, sign informed consent, and follow study requirements
You will not qualify if you...
- Moderate or severe liver impairment (Child-Pugh Class B or C)
- Severe kidney impairment with creatinine clearance less than 15 mL/min
- Pregnant or breastfeeding women
- Spontaneous bleeding tendencies such as coagulation disorders or very low platelet counts (platelets less than 20 x 10^9/L)
- Contraindications to Xa factor inhibitors
- Diagnosed hereditary thrombophilia or antiphospholipid syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year
Participants who are using direct oral anticoagulants for pulmonary embolism are observed to assess anticoagulant efficacy and safety, including recurrence of venous thromboembolism and bleeding events.
Regular assessments during maintenance phase as determined by clinical care
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
J
juhong Shi, M.D
M
min Peng, M.D
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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