Rivaroxaban for the Prevention of Venous Thromboembolism in Asian Patients With Cancer
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
Rivaroxaban has been developed in the various clinical settings, prevention of venous
thromboembolism (VTE)after major orthopedic surgery, prevention of stroke in atrial
fibrillation, and in the treatment of acute coronary syndromes. And, in the
EINSTEIN-pulmonary embolism (PE) and EINSTEIN-deep venous thrombosis (DVT) programs,
rivaroxaban showed non-inferior to standard therapy for the treatment of PE and DVT. However,
there has been limited experience of rivaroxaban with secondary VTE prophylaxis in cancer
patients. Although cancer-associated DVT or PE was included in previously mentioned EINSTEIN
programs, only approximately 5% of the total populations were cancer patients in these
studies. Thus, investigators could not automatically translate the results of these studies
into the real practice management of cancer-associated VTE patients. Moreover, until now, new
oral anticoagulants, including dabigatran and rivaroxaban, have been compared to long-term
warfarin therapy, which were well-known inferior agent, but not low molecular weight heparin.
In this sense, investigators feel that new oral anticoagulants, particularly rivaroxaban,
should be re-investigated in this highly specific patients group. Therefore, investigators
are planning to conduct a prospective study evaluating the efficacy and safety of rivaroxaban
in Korean patients with cancer-associated VTE.
Phase:
Phase 4
Details
Lead Sponsor:
Seoul National University Hospital
Collaborator:
Korean Society of Hematology Thrombosis Working Party