Venous ThromboembolismPhase 4NEXT-CATNCT07852637
Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism
A Phase 4 study testing edoxaban and Apixaban in people with Venous Thromboembolism and Active Cancer, run by Samsung Medical Center at 12 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Venous Thromboembolism, Active Cancer
- What is being tested?
- edoxaban and Apixaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 1 Nov 2026to 31 Dec 2030
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- Pregnancy or breastfeeding.
- Moderate or severe hepatic impairment classified as Child-Pugh class B or C.
- Thrombocytopenia with a platelet count <50,000/mm³.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
South Korea12 sites
Dong-A University Hospital
Busan
Sung-Hyun Kim
Sung-Hyun Kim, MD, PhD
Inje University Ilsan Paik Hospital
Goyang
Min Sun Kim
Min Sun Kim
National Cancer Center
Goyang-si, Gyeonggi-do
Mi-Hyang Kwak
Mi-Hyang Kwak
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong
Eun Jeong Cho
Eun Jeong Cho
Chonnam National University Hwasun Hospital
Hwasun
Hyukjin Park
Hyukjin Park
Chonbuk National University Hospital
Jeonju
Ho-Young Yhim
Ho-Young Yhim, MD, PhD
Kangbuk Samsung Hospital
Seoul
Jiwon Kim
Jiwon Kim
Konkuk University Medical Center
Seoul
Ji-Won Hwang
Ji-Won Hwang
Korea University Anam Hospital
Seoul
So Ree Kim
So Ree Kim
Samsung Medical Center
Seoul
Yunjeong Song, RN, yjung.song@sbri.co.kr
Eun Kyoung Kim, MD, PhD
Seoul National University Hospital
Seoul
Sang-Hoon Na, MD, PhD
Sang-Hoon Na, MD, PhD
Seoul St. Mary's Hospital
Seoul
Mi-Hyang Jung
Mi-Hyang Jung, MD, PhD
About this study
Official title: Net Adverse Clinical Events With EdoXaban Versus Apixaban Treatment in Cancer-Associated Thrombosis
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.
Read the detailed description
Cancer-associated thrombosis (CAT) is an important cause of morbidity and mortality in patients with active cancer. Patients with CAT are at increased risk of both recurrent venous thromboembolism and bleeding during anticoagulant treatment, making the balance between efficacy and safety particularly important when selecting an anticoagulant.
Non-vitamin K antagonist oral anticoagulants have become established treatment options for CAT. Edoxaban and apixaban are both factor Xa inhibitors with demonstrated efficacy and safety in patients with CAT. However, they have been evaluated separately against low-molecular-weight heparin, and direct randomized comparisons between edoxaban and apixaban are lacking. The two agents also differ in dosing frequency, dose-reduction strategies, pharmacokinetic characteristics, and renal elimination. Whether these differences translate into differences in overall clinical outcomes in patients with CAT remains uncertain.
NEXT-CAT is a prospective, multicenter, randomized, open-label, blinded-endpoint trial designed to directly compare edoxaban-based treatment with apixaban-based treatment in patients with active cancer and objectively confirmed venous thromboembolism. A total of 2,300 participants will be randomized in a 1:1 ratio, with randomization stratified by participating center and the presence of gastrointestinal cancer at baseline.
The primary hypothesis is that edoxaban-based treatment is non-inferior to apixaban-based treatment with respect to the incidence of net adverse clinical events (NACE). The primary endpoint is a composite of recurrent venous thromboembolism, venous thromboembolism-related death, or major bleeding according to the International Society on Thrombosis and Haemostasis criteria. Participants will be followed at 1, 3, 6, 9, 12, and 18 months after randomization and annually thereafter, with follow-up continuing until 1 year after enrollment of the last participant.
Clinical events corresponding to the primary and secondary endpoints will be evaluated by an independent Clinical Event Adjudication Committee blinded to treatment allocation.
- Conditions
- Venous Thromboembolism, Active Cancer
- Being tested
- edoxaban, Apixaban
- Keywords
- Cancer-Associated Thrombosis, Cancer-Associated Venous Thromboembolism, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism, Direct Oral Anticoagulant, Edoxaban, Apixaban, Anticoagulation
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
edoxabanDrug
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.
ApixabanDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Edoxaban-based Treatment | Active comparator | Participants 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. Receives: Drug: edoxaban |
| Apixaban-based Treatment | Active comparator | Participants 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. Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization until 1 year after enrollment of the last participant
Secondary outcomes (9)
Recurrent Venous Thromboembolism or Venous Thromboembolism-related Death
Time to the first occurrence of recurrent venous thromboembolism or venous thromboembolism-related death.
Measured: From randomization until 1 year after enrollment of the last participant
Recurrent Venous Thromboembolism
Time to the first occurrence of objectively confirmed recurrent venous thromboembolism, including recurrent deep vein thrombosis or recurrent pulmonary embolism.
Measured: From randomization until 1 year after enrollment of the last participant
Venous Thromboembolism-related Death
Death resulting from objectively confirmed fatal pulmonary embolism, recurrent venous thromboembolism directly leading to death, or unexplained death for which no alternative cause is identified and which is adjudicated as venous thromboembolism-related by the Clinical Event Adjudication Committee.
Measured: From randomization until 1 year after enrollment of the last participant
Major Bleeding According to International Society on Thrombosis and Haemostasis Criteria
Time to the first occurrence of major bleeding according to International Society on Thrombosis and Haemostasis criteria, including fatal bleeding, symptomatic bleeding in a critical area or organ, bleeding causing a decrease in hemoglobin of at least 2 g/dL, or bleeding requiring transfusion of at least 2 units of whole blood or packed red blood cells.
Measured: From randomization until 1 year after enrollment of the last participant
Clinically Relevant Non-major Bleeding
Time to the first occurrence of clinically relevant non-major bleeding, defined as clinically overt bleeding that does not meet the criteria for major bleeding but leads to hospitalization or an increased level of care, medical or surgical treatment, or a change in antithrombotic therapy.
Measured: From randomization until 1 year after enrollment of the last participant
Clinically Relevant Bleeding
Time to the first occurrence of clinically relevant bleeding, defined as a composite of major bleeding or clinically relevant non-major bleeding.
Measured: From randomization until 1 year after enrollment of the last participant
Broad Net Adverse Clinical Events
Time to the first occurrence of a broad net adverse clinical event, defined as a composite of recurrent venous thromboembolism, venous thromboembolism-related death, major bleeding, or clinically relevant non-major bleeding.
Measured: From randomization until 1 year after enrollment of the last participant
All-cause Mortality
Death due to any cause occurring during the study follow-up period.
Measured: From randomization until 1 year after enrollment of the last participant
Permanent Discontinuation Due to Adverse Events
Permanent discontinuation of the assigned study drug due to any adverse event during follow-up.
Measured: From randomization until 1 year after enrollment of the last participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, multicenter, randomized, open label, blinded-endpoint trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Eun Kyoung Kim, Samsung Medical Center
- Investigators
- Eun Kyoung Kim, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852637
- Sponsor's protocol ID
- 2026-07-044
- Acronym
- NEXT-CAT
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in the main publication may be shared with qualified researchers upon reasonable request.