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Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism
Sponsor: Samsung Medical Center
Summary
This prospective, multicenter, randomized, open-label, blinded-endpoint trial aims to compare the clinical efficacy and safety of edoxaban-based treatment versus apixaban-based treatment in patients with cancer-associated venous thromboembolism (CAT). A total of 2,300 patients with active cancer and objectively confirmed venous thromboembolism will be randomized in a 1:1 ratio to receive edoxaban-based or apixaban-based treatment. The primary objective is to determine whether edoxaban-based treatment is non-inferior to apixaban-based treatment with respect to net adverse clinical events (NACE), defined as a composite of recurrent venous thromboembolism, venous thromboembolism-related death, or major bleeding according to the International Society on Thrombosis and Haemostasis criteria.
Official title: Net Adverse Clinical Events With EdoXaban Versus Apixaban Treatment in Cancer-Associated Thrombosis
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2300
Start Date
2026-11-01
Completion Date
2030-12-31
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
edoxaban
Edoxaban is administered orally once daily. The standard dose is 60 mg once daily. The dose is reduced to 30 mg once daily in participants with a creatinine clearance of 15-50 mL/min, body weight ≤60 kg, or concomitant use of specified P-glycoprotein inhibitors. In participants aged ≥80 years who are considered at high risk of bleeding and meet the prespecified criteria, further dose reduction to 15 mg once daily may be considered.
Apixaban
Apixaban is administered orally at a standard dose of 5 mg twice daily. The dose is reduced to 2.5 mg twice daily in participants who meet the prespecified dose-reduction criteria, including those who meet at least two of the following criteria: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL, or those with severe renal impairment with a creatinine clearance of 15-29 mL/min.
Locations (12)
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Dong-A University Hospital
Busan, South Korea
Inje University Ilsan Paik Hospital
Goyang, South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, South Korea
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Seoul St. Mary's Hospital
Seoul, South Korea