About this trial
This is an open label study of apixaban for venous thromboembolism prevention in patients with newly diagnosed grade 4 glioma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologic diagnosis of malignant glioma, World Health Organization (WHO) grade 4, including glioblastoma and astrocytoma, based on recent biopsy or resection.
Age 18 and old
Karnofsky performance status (KPS) 60-100
Acceptable labs, including platelets of greater than or equal to 100,000, glomerular filtration rate (GFR) greater than or equal to 25.
Disqualifiers
Evidence of deep venous thrombosis (DVT), pulmonary embolism (PE), or cerebral vein thrombosis (CVT) within 6 months prior to enrollment on the study.
Pregnancy.
Significant bleeding risk including: history of symptomatic intracranial hemorrhage, active bleeding at time of study registration, clinically significant bleeding within 14 days of study registration, intracranial trauma in the past 6 months, including stroke or traumatic brain injury, major surgery or major procedure within 48 hours.
Allergy to apixaban or contraindication to prophylactic anticoagulation. Contraindications include patients who are currently on unfractionated heparin, low molecular weight heparin, heparin derivatives (examples: fondaparinux), or other direct oral anticoagulants (examples: dabigatran, edoxaban, rivaroxaban), who are either unable or unable to discontinue these agents in favor of the investigational drug. Apixaban is also contraindicated in patients who are on strong CYP3A4 inhibitor and P-glycoprotein inhibitors.
Trial design
Single group
Treatments tested in this trial
Apixaban
DrugOpen label
Treatment groups
Trial outcomes
Primary outcomes
Safety of apixaban as determined by bleeding risk
CTCAE 5 reporting of grade 2 non-Central Nervous System (CNS) hemorrhage or grade 2 new CNS hemorrhage.
Secondary outcomes
Efficacy in prevention of venous thromboembolism
Incidence of VTE
Sponsors and contacts
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University of Vermont Medical Center
Lead sponsor
Dartmouth-Hitchcock Medical Center
Collaborator
MaineHealth
Collaborator