Preventing blood clots in outpatients with newly diagnosed grade 4 glioma using apixaban
Venous Thromboembolism Prevention in Outpatients With Glioma
This trial will test whether taking apixaban can prevent dangerous blood clots in adults newly diagnosed with grade 4 glioma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Vermont Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Burlington, Vermont) |
| Trial ID | NCT05683808 on ClinicalTrials.gov |
What this trial studies
This open-label Phase 2 trial gives apixaban to adults with newly diagnosed WHO grade 4 glioma to prevent venous thromboembolism. Eligible patients with adequate platelets, kidney function, and planned radiation/chemotherapy are enrolled and receive apixaban with regular clinical and imaging follow-up. The study primarily collects safety data on intracranial and other bleeding risks in this high-risk population while recording VTE incidence. Results will help determine whether routine prophylactic anticoagulation is appropriate for patients with grade 4 glioma.
Who should consider this trial
Good fit: Adults (age ≥18) with newly diagnosed WHO grade 4 malignant glioma, KPS 60–100, acceptable labs (platelets ≥100,000 and GFR ≥25), and planned radiation and chemotherapy are ideal candidates.
Not a fit: Patients with recent VTE, active bleeding risk, recent intracranial hemorrhage or major recent surgery, pregnancy, or inadequate labs are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce the number of venous blood clots in patients with high-grade glioma and lower clot-related complications.
How similar studies have performed: Previous trials of primary pharmacologic VTE prevention, including studies using apixaban, have shown safety and efficacy in broader cancer populations but included only small numbers of grade 4 glioma patients, so data in this group remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Burlington, Vermont
- University of Vermont Medical Center — Burlington, Vermont, United States (Recruiting)
Study contacts
- Principal investigator: Alissa A Thomas, MD — University of Vermont Medical Center
- Study coordinator: Alissa A Thomas, MD
- Email: alissa.thomas@med.uvm.edu
- Phone: 802-847-8400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.