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

NCT01989845 | Completed Phase 4

• 1 other identifier: KVTE13-01
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  within the six months after the diagnosis of index VTE

Secondary Outcomes (3)

• incidentally detected VTE

  within six months after the diagnosis of VTE

• Major or clinically relevant non-major bleedings

  within six months after the diagnosis of VTE

• recurrent VTE according to the risk of clinical prediction rule

  within six months after the diagnosis of VTE

Study Arms (1)

oral rivaroxaban in cancer-associated VTE

EXPERIMENTAL

Drug: Rivaroxaban

Interventions

Rivaroxaban DRUG

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

Also known as: Xarelto

oral rivaroxaban in cancer-associated VTE

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Korean Society of Hematology Thrombosis Working Party: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

MeSH Terms

Conditions

Recurrence; Hemorrhage

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Soo-Mee Bang, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 21, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 9, 2017

Record last verified: 2017-01

Locations

KR (1)