Rivaroxaban in Elderly Chinese Venous Thromboembolism Patients

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Dec 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called rivaroxaban in older Chinese patients who have experienced a condition known as venous thromboembolism, which includes serious issues like pulmonary embolism (a blockage in the lungs). The goal is to find the best dosage for elderly patients, especially since they often take multiple medications and may be at higher risk for problems like bleeding. Researchers want to learn how to adjust the dosing of rivaroxaban to keep patients safe while effectively preventing blood clots from happening again.

To be eligible for this study, participants must be adults aged 65 to 74 who have been diagnosed with pulmonary embolism and are currently in the maintenance phase of their anticoagulation treatment (the ongoing treatment to prevent blood clots). They should have a life expectancy of at least three months and be willing to follow the study requirements. However, those with certain health issues, like severe liver or kidney problems, or who are pregnant, cannot participate. If you join this study, you can expect regular follow-ups and blood tests to help researchers understand how the medication works in older adults. This research is important as it aims to improve treatment for a vulnerable group of patients.

Gender

ALL

Eligibility 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.