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Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism

Study acronym: NEXT-CAT
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07852637
Lead Sponsor Samsung Medical Center
Collaborators: Seoul National University Hospital, National Cancer Center, Korea, Seoul St. Mary's Hospital, Dong-A University Hospital, Chonnam National University Hospital, Korea University Anam Hospital, Inje University Ilsan Paik Hospital, Konkuk University Hospital, Kangbuk Samsung Hospital, Sungkyunkwan University, Chung-Ang University Gwangmyeong Hospital, Chonbuk National University Hospital
Conditions
(from sponsor)		 Venous Thromboembolism, Active Cancer
Related terms Pulmonary Embolism, Venous Thromboembolism, Venous Thrombosis
Enrollment 2,300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov