NCT01989845

Rivaroxaban for the Prevention of Venous Thromboembolism in Asian Patients With Cancer

Prospective, Multicenter Study Investigating Efficacy and Safety of Oral Rivaroxaban for the Prevention of Recurrent Venous Thromboembolism in Korean Patients With Cancers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rivaroxaban
• Cancer-associated Thrombosis
• Recurrence
• Bleeding

Interventions

Type	Name	Description
DRUG	Rivaroxaban	Rivaroxaban 15mg twice daily for the first 3 weeks, followed by 20mg once daily during 6 months

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-11-21
• Last updated: 2017-01-09

Locations

1 site across 1 country: South Korea