Rivaroxaban in Elderly Chinese Venous Thromboembolism Patients
Recruiting now
Conditions studied: Pulmonary Embolism, Venous Thromboembolism, Anticoagulant-induced Bleeding
In brief
There's no unified recommendation in clinical practice regarding adjusting dosages for different patient types, especially when adverse events occur. While rivaroxaban typically doesn't require coagulation monitoring, in elderly patients, particularly those with multiple medications, finding appropriate lab indicators becomes crucial to gauge its anticoagulant effect. This aids in evaluating precise rivaroxaban dosing for the elderly, balancing bleeding risks and recurrence. Clinical pharmacological studies suggest that drug pharmacokinetics and pharmacodynamics in different populations can guide dosage optimization. Hence, this study aims to provide a basis for optimizing dosing regimens in high-risk elderly patients in China by exploring pharmacokinetic and pharmacodynamic indicators in clinical practice.
Key facts
- Study ID
- NCT06194617
- Run by
- Peking Union Medical College Hospital
- People needed
- 300
- Starts
- 2021-04-01
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2024-01-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- (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.
You may not qualify if…
- (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 it is running
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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