A prospective, multicenter, open-label, observation study evaluating the efficacy and safety of edoxaban in patients with cancer-associated venous thromboembolism

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0004697
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

(1) Patients = 20 years old and active cancer. *Active cancer is defined as a histologically confirmed solid cancer or hematologic malignancy (except for basal cell or squamous cell carcinoma of the skin), which were diagnosed or treated within the prior 6 months, or as a recurrent/metastatic cancer.
(2) Newly diagnosed, objectively confirmed, symptomatic or incidentally detected proximal lower extremity DVT (I.e., popliteal, femoral, iliac or inferior vena cava vein thrombosis), symptomatic PE, or incidental PE of a segmental or larger pulmonary artery.
(3) Life expectancy > 3 months and an intention of anticoagulation for at least 3 months.
(4) Provide written informed consent.

Exclusion Criteria

(1) Unresected gastric carcinoma or esophageal carcinoma;
(2) Isolated asymptomatic distal DVT, isolated asymptomatic subsegmental PE, or isolated splanchnic vein thrombosis;
(3) History of total gastrectomy;
(4) therapeutic anticoagulation for > 96 hours prior to enrolment to treat current episode of qualifying VTE;
(5) History of recent major or clinically relevant bleeding within the previous 4 weeks;
(6) Hemodynamically unstable PE, indicating systolic blood pressure < 90mmHg at the time of study entry;
(7) ECOG performance status score of 3 or 4;
(8) Overt brain metastasis. Patients who have controlled brain metastasis with a need of prednisone =10mg or equivalent are eligible;
(9) Conditions associated with a high risk of serious bleeding as judged by the investigator (eg, active peptic ulcer or recent neurosurgery), or other serious illness or medical conditions (myocardial infarction within 3 months prior to study entry, active uncontrolled, significant neurologic or psychiatric diseases including dementia or seizure) as judged by the investigator;
(10) Inadequate renal function (calculated creatinine clearance < 30 mL/min) or 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)];
(11) Treatment of qualifying VTE with thrombectomy, insertion of a caval filter, or thrombolysis; (12) Platelet count < 50,000/mL at the time of study entry;
(13) Treatment with aspirin in a dosage of >100 mg/day, clopedogrel > 75 mg/day, or dual antiplatelet therapy (any 2 antiplatelet agents including aspirin plus any other oral or intravenous antiplatelet drug) anticipated to continue during the study;
(14) Concurrent systemic use of strong CYP3A4 inducers (i.e., rifampin, phemobarbital) or strong CYP3A4 inhibitoers (i.e., HIV protease inhibitors, systemic ketoconazole) anticipated to continue during the study;
(15) 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;

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The composite of recurrent VTE or major bleeding.

Secondary Outcome Measures

Name	Time	Method
recurrent VTE, major bleeding, clinically relevant non-major bleeding,arterial thrombosis, validation of Ottawa score, VTE-related death