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NOT YET RECRUITING
NCT07852637
PHASE4

Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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