drugset / Trial / NCT04072068

Study on Impact of Edoxaban Treatment in Cancer Patients With Venous Thromboembolism During Antineoplastic Therapy

NCT04072068

Phase 4 Completed 150 enrolled Italian Oncology Group for Clinical Research
NaSingle-groupOpen-labelTreatment

Summary

This is a multicentric, phase IV study. In this study patients that are receiving an antineoplastic treatment and that have been diagnosed with venous thromboembolism will receive edoxaban as per clinical practice. Edoxaban will be administered according to summary of product characteristics. Patients will receive 6 to 12 months of treatment with edoxaban administered orally. The thromboembolic event will be monitored as per local clinical practice. In this study patients will be evaluated at baseline, at the beginning of therapy with edoxaban, after 1 month (+/- 7 days), after 3, 6 and 12 months (+/- 3 weeks). During these visits, patients will be provided of a diary in which they should report drug intake and interruptions and quality of life questionnaires.

Timeline

Start
2019-06-27
Primary completion
2022-03-08
Completion
2022-03-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Edoxaban Small molecule 30 mg Oral
Subject Edoxaban Small molecule 60 mg Oral