A Phase 4 interventional study of Rivaroxaban in Rivaroxaban, Cancer-associated Thrombosis and Recurrence, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-01-09.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
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.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 127 is above the median of 106 across 849 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
Drug: Rivaroxaban
Rivaroxaban 15mg twice daily for the first 3 weeks, followed by 20mg once daily during 6 months
Also known as: Xarelto
recurrent symptomatic deep venous thrombosis, pulmonary embolism or both
Recurrent DVT will be defined if a new onset non-compressibility of a previously compressible venous segment on ultrasonography is identified or if there is a new constant intraluminal filling defect on venography. Unequivocal extension of the thrombus will be needed to diagnose the recurrence on the same extremity of the first event unless new concomitant PE or DVT in other extremities is confirmed. Recurrent PE will be diagnosed by high probability on ventilation/perfusion lung scan, or by the presence of non-enhancing filling defects in the pulmonary vasculature on pulmonary CT angiogram.
Time frame: within the six months after the diagnosis of index VTE
incidentally detected VTE
Incidentally detected recurrent thrombosis will be defined as objectively-proven thrombosis during the study period by imaging studies that are performed for reasons other than suspected VTE.
Time frame: within six months after the diagnosis of VTE
Major or clinically relevant non-major bleedings
Major bleeding will be defined if it is associated with death, occurs at critical sites (intracranial, intraspinal, intraocular, retroperitoneal, or pericardial area), and results in a need for a transfusion of at least 2 units of packed red cells, or lead to a drop in hemoglobin of more than 2 g/dL. Clinically relevant non-major bleeding will be defined as relevant bleeding that did not meet the criteria for major bleeding but is associated with medical intervention, unscheduled visit, interruption or discontinuation of a study drug, or discomfort or impairment of activities of daily life
Time frame: within six months after the diagnosis of VTE
recurrent VTE according to the risk of clinical prediction rule
Risk of recurrent VTE can be differentiated by risk prediction rule, named Ottawa score. Ottawa score is composed of gender, primary tumor site, stage, and prior VTE and ranged between -3 and 3 score points. Patients with a score \<1 will be considered as having low risk for recurrence and patients with a score \>1 considered as having high risk for recurrence.
Time frame: within six months after the diagnosis of VTE
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital