22/4/2014 Rivaroxaban for the Prevention of Venous Thromboembolism in Asian Patients With Cancer - Full Text View - ClinicalTrials.

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This study is currently recruiting participants.
Verified November 2013 by Seoul National University Hospital
Sponsor:
Seoul National University Hospital
Collaborator:
Korean Society of Hematology Thrombosis Working Party
Information provided by (Responsible Party):
Soo-Mee Bang, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01989845
First received: November 5, 2013
Last updated: November 21, 2013
Last verified: November 2013
History of Changes
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A service of the U.S. National Institutes of Health
Rivaroxaban for the Prevention of Venous Thromboembolism in Asian Patients With Cancer
Purpose
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.
Condition Intervention Phase
Rivaroxaban
Cancer-associated Thrombosis
Recurrence
Bleeding
Drug: Rivaroxaban Phase 4
Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Multicenter Study Investigating Efficacy and Safety of Oral Rivaroxaban for the Prevention of Recurrent Venous
Thromboembolism in Korean Patients With Cancers
Resource links provided by NLM:
MedlinePlus related topics: Blood Thinners Cancer Deep Vein Thrombosis Pulmonary Embolism
Drug Information available for: Rivaroxaban
U.S. FDA Resources
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
22/4/2014 Rivaroxaban for the Prevention of Venous Thromboembolism in Asian Patients With Cancer - Full Text View - ClinicalTrials.gov
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recurrent symptomatic deep venous thrombosis, pulmonary embolism or both [ Time Frame: within the six months after the diagnosis of index
VTE ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
incidentally detected VTE [ Time Frame: within six months after the diagnosis of VTE ] [ Designated as safety issue: No ]
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 ]
[ Designated as safety issue: Yes ]
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 ]
[ Designated as safety issue: No ]
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.
Estimated Enrollment: 127
Study Start Date: October 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oral rivaroxaban in cancer-
associated VTE
Drug: Rivaroxaban
Rivaroxaban 15mg twice daily for the first 3 weeks, followed by 20mg once daily during
6 months
Other Name: Xarelto
Eligibility
Ages Eligible for Study: 20 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Patients 20 years old and active cancer and newly-diagnosed, symptomatic or incidental proximal lower extremity DVT, PE or both
will have a life expectancy > 3 months
will be treated with anticoagulation therapy for at least 3 months.
Exclusion Criteria:
(1) Isolated asymptomatic distal DVT
(2) Intra-abdominal venous thrombosis or vascular access-induced thrombosis
(3) Hemodynamically unstable PE, indicating systolic blood pressure <90 mmHg
(4)Eastern Cooperative Oncology Group (ECOG) performance status score of 3 or 4
(5) History of total gastrectomy
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(6) Overt brain metastasis. Patients who have controlled brain metastasis without need of glucocorticoid are eligible
(7) History of recent major or clinically relevant bleeding within the previous 4 weeks
(8) Conditions associated with a high risk of serious bleeding (active peptic ulcer or recent neurosurgery)
(9) Other serious illness or medical conditions (illnesses requiring chronic anticoagulation therapy, unstable cardiac disease despite
treatment, myocardial infarction within 3 months prior to study entry, significant neurologic or psychiatric diseases including dementia or
seizure, active uncontrolled infection, other serious medical conditions)
(10)Inadequate renal function; creatinine clearance < 30 ml/min
(11) Inadequate hepatic function: alanine aminotransferase > 3 times the upper limit of normal (ULN) (if liver metastasis, alanine
aminotransferase > 5 times the ULN or total bilirubin >2 times the ULN (if liver metastasis, total bilirubin >3 times the ULN)
(12) Baseline platelet count < 75,000 per cubic millimeter or Hb < 8g/dL
(13) Plan of treatment with bevacizumab or other anti-cancer drugs known to increase the bleeding risk
(14) Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the
entire study period, who are using a prohibited contraceptive method, or who are pregnant or breastfeeding
(15) Patients requiring strong cytochrome P450 3A4 (CYP3A4) inducers (rifampin, phenobarbital) or strong CYP3A4 inhibitors (HIV protease
inhibitor, systemic ketoconazole) treatments
(16) Patients with inferior vena cava filter placement or underwent catheter-directed thrombolysis or stent placement for the treatment of
index VTE
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01989845
Contacts
Contact: Soo-Mee Bang, MD, PhD 82-31-787-7039 smbang7@snu.ac.kr
Contact: Ho-Young Yhim, MD, PhD 82-63-250-2523 yhimhy@jbnu.ac.kr
Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 463-707
Contact: Soo-Mee Bang, MD, PhD 82-31-787-7039 smbang7@snu.ac.kr
Principal Investigator: Ho-Young Yhim, MD, PhD
Principal Investigator: Inho Kim, MD, PhD
Principal Investigator: Kyoung Ha Kim, MD, PhD
Principal Investigator: Sung Hwa Bae, MD, PhD
Principal Investigator: Yeung-Chul Mun, MD, PhD
Principal Investigator: Sung-Hyun Kim, MD, PhD
Principal Investigator: Hun Gyu Hwang, MD, PhD
Principal Investigator: Yang-Ki Kim, MD, PhD
Principal Investigator: Won-Il Choi, MD, PhD
Principal Investigator: Seung-Hyun Nam, MD, PhD
Sponsors and Collaborators
Seoul National University Hospital
Korean Society of Hematology Thrombosis Working Party
Investigators
Principal Investigator: Soo-Mee Bang, MD, PhD Seoul National University Bundang Hospital
More Information
No publications provided
Responsible Party: Soo-Mee Bang, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01989845 History of Changes
Other Study ID Numbers: KVTE13-01
Study First Received: November 5, 2013
Last Updated: November 21, 2013
22/4/2014 Rivaroxaban for the Prevention of Venous Thromboembolism in Asian Patients With Cancer - Full Text View - ClinicalTrials.gov
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Health Authority: Korea: Food and Drug Administration
Additional relevant MeSH terms:
Hemorrhage
Recurrence
Thromboembolism
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Pathologic Processes
Disease Attributes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
ClinicalTrials.gov processed this record on April 21, 2014