Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism
NEXT-CAT
Net Adverse Clinical Events With EdoXaban Versus Apixaban Treatment in Cancer-Associated Thrombosis
1 other identifier
interventional
2,300
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2026
Longer than P75 for phase_4
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2026
CompletedFirst Posted
Study publicly available on registry
October 1, 2026
CompletedStudy Start
First participant enrolled
November 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
Study Completion
Last participant's last visit for all outcomes
December 31, 2030
October 1, 2026
September 1, 2026
3.2 years
September 25, 2026
September 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Net Adverse Clinical Events (NACE)
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.
From randomization until 1 year after enrollment of the last participant
Secondary Outcomes (9)
Recurrent Venous Thromboembolism or Venous Thromboembolism-related Death
From randomization until 1 year after enrollment of the last participant
Recurrent Venous Thromboembolism
From randomization until 1 year after enrollment of the last participant
Venous Thromboembolism-related Death
From randomization until 1 year after enrollment of the last participant
Major Bleeding According to International Society on Thrombosis and Haemostasis Criteria
From randomization until 1 year after enrollment of the last participant
Clinically Relevant Non-major Bleeding
From randomization until 1 year after enrollment of the last participant
- +4 more secondary outcomes
Study Arms (2)
Edoxaban-based Treatment
ACTIVE COMPARATORParticipants randomized to this arm will receive oral edoxaban once daily. The standard dose is 60 mg once daily, with dose reduction according to the protocol based on renal function, body weight, concomitant P-glycoprotein inhibitors, and other prespecified clinical factors.
Apixaban-based Treatment
ACTIVE COMPARATORParticipants randomized to this arm will receive oral apixaban twice daily. The standard dose is 5 mg twice daily, with dose reduction to 2.5 mg twice daily according to the prespecified dose-reduction criteria in the protocol.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Age ≥19 years.
- Objectively confirmed symptomatic or incidentally detected venous thromboembolism (VTE), including:
- Proximal deep vein thrombosis (DVT)
- Pulmonary embolism (PE)
- Both DVT and PE.
- 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.
- Ability to understand the risks, benefits, and treatment alternatives of the study and to voluntarily provide written informed consent.
You may not qualify if:
- Known hypersensitivity or contraindication to either study drug (edoxaban or apixaban).
- Severe renal impairment (creatinine clearance \<15 mL/min) or dialysis.
- Active major bleeding.
- An indication requiring alternative anticoagulation, such as a mechanical heart valve or moderate-to-severe mitral stenosis.
- Antiphospholipid syndrome.
- Life expectancy \<6 months due to cancer progression or comorbid conditions, or anticipated poor treatment adherence, as determined by the investigator.
- Pregnancy or breastfeeding.
- Moderate or severe hepatic impairment classified as Child-Pugh class B or C.
- Thrombocytopenia with a platelet count \<50,000/mm³.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Seoul National University Hospitalcollaborator
- National Cancer Center, Koreacollaborator
- Dong-A University Hospitalcollaborator
- Korea University Anam Hospitalcollaborator
- Chonbuk National University Hospitalcollaborator
- Seoul St. Mary's Hospitalcollaborator
- Chonnam National University Hospitalcollaborator
- Inje University Ilsan Paik Hospitalcollaborator
- Chung-Ang University Gwangmyeong Hospitalcollaborator
- Konkuk University Hospitalcollaborator
- Kangbuk Samsung Hospital, Sungkyunkwan Universitycollaborator
Study Sites (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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eun Kyoung Kim
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The study uses a prospective randomized open-label, blinded-endpoint (PROBE) design. Participants and treating investigators are aware of treatment assignment, while clinical events corresponding to the study endpoints are adjudicated by an independent Clinical Event Adjudication Committee blinded to treatment allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 25, 2026
First Posted
October 1, 2026
Study Start (Estimated)
November 1, 2026
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2030
Last Updated
October 1, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning after publication of the main study results; no predetermined end date.
- Access Criteria
- Data may be made available to qualified researchers upon reasonable request for scientifically appropriate research purposes. Requests will be reviewed by the principal investigator and the study steering committee based on the scientific merit and appropriateness of the proposed research and data-use plan. Data sharing will be conducted in accordance with applicable regulations and participant privacy requirements.
De-identified individual participant data that underlie the results reported in the main publication may be shared with qualified researchers upon reasonable request.