Venous Thromboembolism Prevention in Outpatients With Glioma (VTE-POG)

University of Vermont Medical Center

Status and phase

Enrolling

Phase 2

Conditions

Venous Thromboembolism

Glioblastoma

Astrocytoma

Treatments

Drug: Apixaban

Study type

Interventional

Funder types

Other

Identifiers

NCT05683808

NNECOS004

Details and patient eligibility

About

This is an open label study of apixaban for venous thromboembolism prevention in patients with newly diagnosed grade 4 glioma.

Full description

Patients with primary brain tumors, including glioblastoma and astrocytoma, are at high risk of developing venous thromboemboli (VTE) as a comorbid condition. Prior studies have demonstrated safety and efficacy of primary pharmacological prevention of VTE using blood thinning medications, including apixaban. These studies have included a small cohort of patients with grade 4 glioma. The purpose of this study is to gather additional safety data regarding the use of apixaban for primary prevention of VTE in patients with newly diagnosed grade 4 glioma.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.
Ability to provide informed consent.
Planning for treatment with radiation and chemotherapy.

Exclusion criteria

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.
Indication for full anticoagulation (i.e. atrial fibrillation, mechanical valve, etc.).
Estimated life expectancy of <3 months.