Status:
COMPLETED
Study on Impact of Edoxaban Treatment in Cancer Patients With Venous Thromboembolism During Antineoplastic Therapy
Lead Sponsor:
Gruppo Oncologico Italiano di Ricerca Clinica
Conditions:
Thromboembolism
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 clin...
Eligibility Criteria
Inclusion
- Adult subjects presenting with VTE (venous thromboembolism) associated with cancer (other than basal-cell or squamous-cell carcinoma of the skin). Cancer diagnosis should be done within two years prior to VTE.
- Patient must be receiving systemic antineoplastic therapy (such as chemotherapy, target therapy, immunotherapy, hormonotherapy) and remain candidate to receive at least other 3 months of anti neoplastic therapy.
Exclusion
- Hypersensitivity to the active substance or to any of the excipients;
- Clinically significant active bleeding;
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk;
- Lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities;
- Uncontrolled severe hypertension;
- Concomitant treatment with any other anticoagulants
- Pregnancy and breast-feeding.
Key Trial Info
Start Date :
June 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04072068
Start Date
June 27 2019
End Date
March 8 2022
Last Update
May 30 2023
Active Locations (18)
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1
Presidio Ospedaliero SS. Antonio e Biagio
Alessandria, Italy
2
Istituto Tumori di Bari
Bari, Italy
3
Azienda Ospedalier Spedali Civili di Brescia
Brescia, Italy
4
Ospedale S.Giacomo
Castelfranco Veneto, Italy