Venous Thromboembolism Prevention in Outpatients With Glioma

NCT ID: NCT05683808

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-16
• Study Completion Date: 2027-06-30

Brief Summary

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

Detailed 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.

Conditions

Glioblastoma; Astrocytoma; Venous Thromboembolism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Single arm study

Group Type: EXPERIMENTAL

Apixaban

Intervention Type: DRUG

Open label

Interventions

Apixaban

Open label

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: collaborator

MaineHealth

OTHER

Sponsor Role: collaborator

University of Vermont Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alissa Thomas

Associate Professor of Neurological Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alissa A Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont Medical Center

Locations

University of Vermont Medical Center

Burlington, Vermont, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alissa A Thomas, MD

Role: CONTACT

alissa.thomas@med.uvm.edu

802-847-8400

Donna Silver

Role: CONTACT

irb@uvm.edu

802-656-5040

Other Identifiers

NNECOS004

Identifier Type: -

Identifier Source: org_study_id