Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
NCT ID:
NCT04072068
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04072068
Study Brief:
Protocol Section:
NCT04072068