NCT05683808 Venous Thromboembolism Prevention in Outpatients With Glioma
| NCT ID | NCT05683808 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Vermont Medical Center |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-01-16 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2023-01-16 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open label study of apixaban for venous thromboembolism prevention in patients with newly diagnosed grade 4 glioma.
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.
Contact & Investigator
Alissa A Thomas, MD
PRINCIPAL INVESTIGATOR
University of Vermont Medical Center
Frequently Asked Questions
Who can join the NCT05683808 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05683808 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05683808 currently recruiting?
Yes, NCT05683808 is actively recruiting participants. Contact the research team at alissa.thomas@med.uvm.edu for enrollment information.
Where is the NCT05683808 trial being conducted?
This trial is being conducted at Burlington, United States.
Who is sponsoring the NCT05683808 clinical trial?
NCT05683808 is sponsored by University of Vermont Medical Center. The principal investigator is Alissa A Thomas, MD at University of Vermont Medical Center. The trial plans to enroll 40 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.