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

NCT ID: NCT01989845

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

oral rivaroxaban in cancer-associated VTE

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

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

Interventions

Rivaroxaban

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

Intervention Type: DRUG

Other Intervention Names

Xarelto

Eligibility 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
• (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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korean Society of Hematology Thrombosis Working Party

UNKNOWN

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soo-Mee Bang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soo-Mee Bang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam, , South Korea

Countries

South Korea

Other Identifiers

KVTE13-01

Identifier Type: -

Identifier Source: org_study_id