Clinical trial NCT01989845: Rivaroxaban for the Prevention of Venous Thromboembolism in Asian Patients With Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rivaroxaban
Cancer-associated Thrombosis
Recurrence
Bleeding
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korean Society of Hematology Thrombosis Working Party
First posted: 2013-11-21
Enrollment: 127
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: recurrent symptomatic deep venous thrombosis, pulmonary embolism or both
timeFrame: within the six months after the diagnosis of index VTE
Secondary outcomes:
measure: incidentally detected VTE
timeFrame: within six months after the diagnosis of VTE
measure: Major or clinically relevant non-major bleedings
timeFrame: within six months after the diagnosis of VTE
measure: recurrent VTE according to the risk of clinical prediction rule
timeFrame: within six months after the diagnosis of VTE
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo-Mee Bang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: