NCT07852637Not yet recruitingPhase 4
Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism
Net Adverse Clinical Events With EdoXaban Versus Apixaban Treatment in Cancer-Associated Thrombosis
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2300 (estimated)
- First submitted
- 25 Sept 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Samsung Medical Center
- NCT number
- NCT07852637
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 2300
- From 1 Nov 2026 to the primary completion date, 31 Dec 2029
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known hypersensitivity or contraindication to either study drug (edoxaban or apixaban).
- 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.
- Moderate or severe hepatic impairment classified as Child-Pugh class B or C.
Lab values
- Severe renal impairment (creatinine clearance \<15 mL/min) or dialysis.
- Thrombocytopenia with a platelet count \<50,000/mm³.
Other
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dong-A University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Inje University Ilsan Paik Hospital Coordinator of this site? Confirm its status | Goyang | South Korea | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Chung-Ang University Gwangmyeong Hospital Coordinator of this site? Confirm its status | Gwangmyeong | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Unknown status |
| Chonbuk National University Hospital Coordinator of this site? Confirm its status | Jeonju | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Konkuk University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.