Clinical trial · Interventional
Venous Thromboembolism Prevention in Outpatients With Glioma
NCT05683808CI-TRIAL-00102068VTE-POGrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open label study of apixaban for venous thromboembolism prevention in patients with newly diagnosed grade 4 glioma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma | Astrocytoma | CURATED_BROADER | 0.80 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apixaban | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm study
- interventionNames
- Drug: Apixaban
Primary outcomes (1)
- measure
- Safety of apixaban as determined by bleeding risk
- timeFrame
- 6 months
- description
- CTCAE 5 reporting of grade 2 non-Central Nervous System (CNS) hemorrhage or grade 2 new CNS hemorrhage.
Secondary outcomes (1)
- measure
- Efficacy in prevention of venous thromboembolism
- timeFrame
- 6 months
- description
- Incidence of VTE
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.