Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism
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.
Timeline
- Start
- 2026-11-01
- Primary completion
- 2029-12-31
- Completion
- 2030-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Apixaban | Small molecule | 2.5 mg | Oral |
| Comparator | Apixaban | Small molecule | 5 mg | Oral |
| Comparator | Edoxaban | Small molecule | 15 mg | Oral |
| Comparator | Edoxaban | Small molecule | 30 mg | Oral |
| Comparator | Edoxaban | Small molecule | 60 mg | Oral |