Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism

NCT07852637 · tracked via the Priya Life Science South Korea tracker

Sponsor

Samsung Medical Center

Phase

Phase 4

Started

2026-11-01

Last updated

2026-10-01

Condition(s) studied

Venous ThromboembolismActive Cancer

Investigational drug(s) / intervention(s)

edoxaban →Apixaban →

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.

Study 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.

Eligibility

Sex

ALL

Min age

19 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age ≥19 years. 2. Objectively confirmed symptomatic or incidentally detected venous thromboembolism (VTE), including: * Proximal deep vein thrombosis (DVT) * Pulmonary embolism (PE) * Both DVT and PE. 3. Any type of active cancer, defined by at least one of the following: * Cancer diagnosed within the previous 6 months * Locally advanced or metastatic cancer * Receipt of cancer-directed therapy (chemotherapy, immunotherapy, targeted therapy, endocrine therapy, radiotherapy, or cancer surgery) within the previous 6 months * Cancer not in complete remission at the time of enrollment * Ongoing cancer treatment or residual cancer. 4. Ability to understand the risks, benefits, and treatment alternatives of the study and to voluntarily provide written informed consent. Exclusion Criteria: 1. Known hypersensitivity or contraindication to either study drug (edoxaban or apixaban). 2. Severe renal impairment (creatinine clearance \<15 mL/min) or dialysis. 3. Active major bleeding. 4. An indication requiring alternative anticoagulation, such as a mechanical heart valve or moderate-to-severe mitral stenosis. 5. Antiphospholipid syndrome. 6. Life expectancy \<6 months due to cancer progression or comorbid conditions, or anticipated poor treatment adherence, as determined by the investigator. 7. Pregnancy or breastfeeding. 8. Moderate or severe hepatic impairment classified as Child-Pugh class B or C. 9. Thrombocytopenia with a platelet count \<50,000/mm³.

Primary outcome measure(s)

Net Adverse Clinical Events (NACE) — From randomization until 1 year after enrollment of the last participant
Time to the first occurrence of a net adverse clinical event, defined as a composite of recurrent venous thromboembolism, venous thromboembolism-related death, or major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) criteria.

Trial sites (12)

Facility	City	Region
National Cancer Center	Goyang-si	Gyeonggi-do
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

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07852637 on ClinicalTrials.gov ↗ ← All trials in South Korea