Recruiting
Phase 2

Apixaban

Sponsor:

University of Vermont Medical Center

Code:

NCT05683808

Conditions

Glioblastoma

Astrocytoma

Venous Thromboembolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Apixaban

Study Details

Brief summary:

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

Conditions

Glioblastoma

Astrocytoma

Venous Thromboembolism

Study ID

NCT05683808

Start date

Jan 16, 2023

Status verified date

Dec, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Single arm study

Interventions

Apixaban

Open label

Primary outcome measure

  • Safety of apixaban as determined by bleeding risk [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Alissa A Thomas, MD

802-847-8400alissa.thomas@med.uvm.edu

Donna Silver

802-656-5040irb@uvm.edu

Locations

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

More Information

Sponsor

University of Vermont Medical Center

Last update posted

Jan 30, 2026

Last verified

Dec, 2025

Keywords

  • High grade glioma
  • Glioblastoma
  • Astrocytoma
  • Venous thromboembolism
  • Apixaban

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont Medical Center on 2026-01-30.