Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms

Condition(s) studied

Investigational drug(s) / intervention(s)

Methylprednisolone (Injectable Form): This clinical study involves a perioperative pharmacological intervention using Methylprednisolone (Methylprednisolone Sodium Succinate for injection). The intervention is characterized by a weight-based, short-course intravenous regimen initiated preoperatively. The specific and distinguishing protocol is as follows: Drug \& Form: Methylprednisolone Sodium Succinate, injectable formulation. Route \& Method: Intravenous infusion, dissolved in normal saline, administered at a rate of 40-60 drops per minute. Dosing: 2 mg per kilogram of body weight per dose, with a maximum single dose not exceeding 160 mg. Timing \& Duration: The regimen begins preoperatively on the day of surgery (Day 1). It is administered once daily (qd) for a total of 3 consecutive days. This protocol defines a distinct perioperative corticosteroid strategy aimed at modulating the inflammatory response associated with flow-diverting device implantation. It is an add-on therapy to the standard surgical and antiplat

Placebo Injection: The placebo intervention is characterized by a volume-matched, short-course intravenous regimen designed to be indistinguishable from the active drug in all aspects of administration except for the active pharmaceutical ingredient. The specific and distinguishing protocol is as follows: Drug \& Form: Matched Placebo (0.9% Sodium Chloride Injection), provided in an identical injectable formulation. Route \& Method: Intravenous infusion, administered at an identical rate of 40-60 drops per minute. Dosing: The infusion contains no active drug. The volume of each infusion is matched to the volume of the Methylprednisolone solution prepared for a participant of equivalent weight in the experimental group. Timing \& Duration: The regimen begins preoperatively on the day of surgery (Day 1). It is administered once daily (qd) for a total of 3 consecutive days, precisely mirroring the active treatment schedule.

Study summary

Study Title: Testing Methylprednisolone to Prevent Strokes After a Stent Procedure for Brain Aneurysms

What is the purpose of this study? This study aims to find out if a short course of a steroid medicine called methylprednisolone can help prevent strokes and other brain-related complications in patients who have a "flow diverter" stent placed to treat an unruptured brain aneurysm. The main goal is to see if this treatment reduces the combined number of new strokes (both clot-related and bleeding-related) or brain injury-related deaths within the first 30 days after the procedure.

Who can participate? Adults aged 18 or older with an unruptured brain aneurysm (size 3-25mm) who are scheduled to receive a flow-diverting stent and can provide informed consent may be eligible. Key reasons someone might not be able to join include: having multiple aneurysms needing quick treatment, being pregnant or breastfeeding, having a history of recent stroke, having active infections or stomach ulcers, having severe kidney disease, having very high/uncontrolled blood pressure or blood sugar, or already being on long-term steroid therapy.

What will happen in the study?

This is a multicenter, randomized, double-blind study. This means:

Participants will be randomly assigned (like flipping a coin) to one of two groups.

One group will receive methylprednisolone. The other group will receive a placebo (an inactive substance that looks identical).

Neither the participants nor their doctors will know which treatment is being given.

All participants will receive the standard care for the stent procedure and aftercare.

How long will the study last? The treatment period is short (around the time of the procedure). Participants will be closely monitored in the hospital and will have a follow-up visit around 30 days after the procedure to check their health status.

What will be measured? The researchers will mainly track whether participants have any stroke or brain injury-related death in the first 30 days. They will also check for other complications like bleeding, infections, and changes in daily function and quality of life. Safety will be monitored throughout.

How many people will take part? The study plans to enroll approximately 864 participants across multiple hospitals.

Study Dates:

The study is expected to start enrolling patients in January 2026 and finish in August 2027.

Who is organizing the study? This study is sponsored and led by Zhujiang Hospital, Southern Medical University.

Eligibility

Primary outcome measure(s)

• Incidence of the Composite Outcome of Any New Cerebrovascular Adverse Event and Neurologic Death within 30 Days — From the implantation procedure (Day 1) up to 30 days post-procedure (assessed at visits V2 to V5).
  This primary efficacy endpoint measures the proportion of participants experiencing at least one of the following within 30 days post-implantation: a new ischemic event (ischemic stroke, stent thrombosis, or urgent revascularization), a new hemorrhagic event (any intracranial hemorrhage classified by the Heidelberg Bleeding Classification), or neurologic death. The outcome is calculated as the number of participants meeting this composite definition divided by the total participants in the group, multiplied by 100%.

Trial sites (1)

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