Phase 4Not yet recruiting
Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism (NEXT-CAT)
Net Adverse Clinical Events With EdoXaban Versus Apixaban Treatment in Cancer-Associated Thrombosis
- Sponsor
- Samsung Medical Center (Academic or other)
- Enrolment
- 2,300 planned
- Conditions
- Venous Thromboembolism; Active Cancer
- Interventions
- edoxaban; Apixaban
- Ages
- adults, older adults
- Registry
- NCT07852637
From the registry
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.
Primary outcomes
- Net Adverse Clinical Events (NACE)