A Phase IV study on impact of Edoxaban treatment in Italian cancer patients with venous thromboembolism (EDOI Cancer Study) during antineoplastic therapy - EDOI

GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)0 个研究点目标入组 300 人开始时间: 2021年1月7日最近更新: 2021年1月11日

适应症

试验速览

暂无简介。

•- Adult subjects presenting with VTE associated with cancer.
•- Patient must be receiving sistemic antineoplastic therapy (such as chemotherapy, target therapy, immuntherapy, ormonotherapy) and remain candidate to receive at least other 3 months of anti neoplastic therapy.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 180

•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.

发起方

GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)