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.
（1）Aged ≥ 18 years; （2）Diagnosed with intracranial aneurysm (IA) via CTA, MRA, or DSA;
（1）Patients with two or more multiple aneurysms who require secondary treatment within one month; （2）Female patients who are planning to become pregnant, are pregnant, or are breastfeeding;
Parallel
Methylprednisolone (Injectable Form)
DrugThis 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
DrugThe 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.
Incidence of the Composite Outcome of Any New Cerebrovascular Adverse Event and Neurologic Death within 30 Days
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%.
Incidence of Any Cerebrovascular Adverse Event
The proportion of participants with any new cerebrovascular adverse event (ischemic or hemorrhagic, as per primary outcome definitions) assessed at specific postoperative intervals.
Incidence of Any Ischemic Brain Event
The proportion of participants experiencing an ischemic brain event, including ischemic stroke, TIA, stent thrombosis, urgent revascularization, or cerebrovascular death.
Incidence of Any Hemorrhagic Brain Event
The proportion of participants experiencing a hemorrhagic brain event, defined as intraparenchymal hemorrhage, subarachnoid hemorrhage, or subdural hematoma.
Functional Outcome - mRS Score Distribution
The proportion of participants classified with favorable (mRS score 0-2) and unfavorable (mRS score 3-5) functional outcomes based on the modified Rankin Scale at 30 days.
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Duan Chuanzhi
Lead sponsor
Zhujiang Hospital
Sponsor institution
Nanfang Hospital, Southern Medical University
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Beijing Tiantan Hospital
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
The Affiliated Hospital Of Southwest Medical University
Collaborator
Guangdong 999 Brain Hospital
Collaborator
Eighth Affiliated Hospital, Sun Yat-sen University
Collaborator
ZhuHai Hospital
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
Henan Provincial People's Hospital
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Second Affiliated Hospital of Nanchang University
Collaborator
West China Hospital
Collaborator
Shengjing Hospital
Collaborator
Tongji Hospital
Collaborator
Zunyi Medical College
Collaborator
Qilu Hospital of Shandong University
Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
The Third Affiliated Hospital of Southern Medical University
Collaborator
Dongguan People's Hospital
Collaborator
Shantou Central Hospital
Collaborator
Guilin Medical University, China
Collaborator
Huizhou Third People's Hospital, Guangzhou Medical University
Collaborator
Guangdong Provincial Hospital of Integrated Traditional Chinese and Western Medicine
Collaborator
Qingyuan People's Hospital
Collaborator
Guigang People's Hospital
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
The First Affiliated Hospital of Guangzhou Medical University
Collaborator
First Affiliated Hospital of Jinan University
Collaborator
Shenzhen People's Hospital
Collaborator
Meizhou People's Hospital
Collaborator
First People's Hospital of Foshan
Collaborator
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