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Methylprednisolone to Prevent Strokes After a Stent Procedure for Brain Aneurysms
NCT07353749Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Nov 2026
- Primary completion
- Dec 2028
- Countries
- 1
- Sponsor
- Chuanzhi Medical
- Modality
- Orthosteric Ligands
- Conditions
- brain aneurysm (IA)
01
Overview
Phase 4, randomised, double-blind trial in brain aneurysm (IA) comparing Methylprednisolone Group with Placebo Control Group (2 arms). Primary endpoint: Incidence of Any New Stroke or All-Cause Death at 30 days. Planned start Nov 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Methylprednisolone Group
Methylprednisolone sodium succinate for injection (2 mg/kg/day, max 160 mg) IV for 3 days.
Placebo Control Group
Matched placebo IV for 3 days.
03
Who it enrols
Adults with unruptured intracranial aneurysms (3-25mm) planned for flow-diverter treatment, excluding those with posterior circulation aneurysms, recent stroke, severe comorbidities, or contraindications to glucocorticoids.
04
Endpoints
Primary
Incidence of Any New Stroke or All-Cause Death
Secondary
Incidence of Any Cerebral Ischemic Event
Incidence of In-Stent Thrombosis
Incidence of Emergency Revascularization
Incidence of Any Cerebral Hemorrhagic Event
All-Cause Mortality
Proportion of Participants With Modified Rankin Scale Score 0-2
Proportion of Participants With Modified Rankin Scale Score 3-5
Incidence of Transient Ischemic Attack
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