Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism

ConditionsVenous Thromboembolism Active Cancer

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age19+

SponsorSamsung Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥19 years.

Proximal deep vein thrombosis (DVT)

Pulmonary embolism (PE)

Both DVT and PE.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

edoxaban
Drug
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
Drug
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.

Treatment groups

2,300 Participants

are divided into 2 treatment groups

Group A: Edoxaban-based TreatmentActive comparator 1 intervention

Group B: Apixaban-based TreatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame