Rivaroxaban for the Prevention of Venous Thromboembolism in Asian Patients With Cancer
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|ClinicalTrials.gov Identifier: NCT01989845|
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : January 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rivaroxaban Cancer-associated Thrombosis Recurrence Bleeding||Drug: Rivaroxaban||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Multicenter Study Investigating Efficacy and Safety of Oral Rivaroxaban for the Prevention of Recurrent Venous Thromboembolism in Korean Patients With Cancers|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
|Experimental: oral rivaroxaban in cancer-associated VTE||
Rivaroxaban 15mg twice daily for the first 3 weeks, followed by 20mg once daily during 6 months
Other Name: Xarelto
- recurrent symptomatic deep venous thrombosis, pulmonary embolism or both [ Time Frame: within the six months after the diagnosis of index VTE ]
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.
- incidentally detected VTE [ Time Frame: within six months after the diagnosis of 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.
- Major or clinically relevant non-major bleedings [ Time Frame: within six months after the diagnosis of VTE ]
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
- recurrent VTE according to the risk of clinical prediction rule [ Time Frame: within six months after the diagnosis of VTE ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989845
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Korea, Republic of, 463-707|
|Principal Investigator:||Soo-Mee Bang, MD, PhD||Seoul National University Bundang Hospital|