Rivaroxaban in Elderly Chinese Venous Thromboembolism Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
(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.
Disqualifiers
(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.
Trial population
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。
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Direct oral anticoagulant
DrugPatients take DOACs according to their condition, with the dosage determined by the clinical physician.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Patients with pulmonary embolism and using direct oral anticoagulants1 intervention
Trial outcomes
Primary outcomes
1
Symptomatic recurrence of VTE.
Recurrent VTE.
Time frame
through study completion, an average of 1 year2
Fatal or non-fatal PTE.
Recurrent VTE.
Time frame
through study completion, an average of 1 year3
Major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) events as defined by the International Society on Thrombosis and Haemostasis (ISTH).
Bleeding Events
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov