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NCT07353749

PHASE4

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

Sponsor: Duan Chuanzhi

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Methylprednisolone in Preventing Adverse Cerebrovascular Events After Flow-Diverter Stent Implantation in Patients With Unruptured Intracranial Aneurysms: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

864

Start Date

2026-01-30

Completion Date

2027-09-01

Last Updated

2026-01-20

Healthy Volunteers

Conditions

Unruptured Intracranial Aneurysms Cerebrovascular Event Hemorrhagic Stroke Methylprednisolone Flow Diverter

Interventions

DRUG

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

DRUG

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.

Inclusion Criteria: * （1）Aged ≥ 18 years; （2）Diagnosed with intracranial aneurysm (IA) via CTA, MRA, or DSA; （3）IA size ranging from 3 to 25 mm; （4）The patient and/or their authorized representative can understand the study purpose, voluntarily participate, and sign the informed consent form; （5）Patients scheduled to receive flow diverter treatment; （6）Patients willing to complete follow-up evaluations in accordance with the clinical study protocol. Exclusion Criteria: * （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; （3）Pre-onset modified Rankin Scale (mRS) score ≥ 2; （4）Patients complicated with systemic infectious diseases (latent or active stage), ulcerative colitis, diverticulitis, liver cirrhosis, myasthenia gravis, or ocular herpes simplex; patients with contraindications to glucocorticoids, such as active peptic ulcer and severe fungal infection; （5）Ruptured aneurysms, recurrent aneurysms, infectious aneurysms, dissecting aneurysms; complicated with arteriovenous malformation, dural arteriovenous fistula, spinal dural arteriovenous fistula, moyamoya disease, etc.; （6）Patients with symptomatic cerebrovascular stenosis ≥ 70%; （7）Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 30 days; （8）Patients scheduled to undergo other surgical/interventional procedures within 30 days; （9）Patients with severe comorbidities unsuitable for anesthesia or surgical treatment, such as major diseases of the heart, lungs, liver, spleen, and kidneys, atrial fibrillation, brain tumors, severe active infections, disseminated intravascular coagulation, and severe psychiatric history; （10）Patients who cannot receive antiplatelet aggregation or anticoagulant therapy; （11）Hypersensitivity to methylprednisolone sodium succinate; （12）Patients receiving long-term hormone therapy (≥ 1 week) due to other comorbidities before surgery; （13）Patients taking hepatic enzyme-inducing drugs, such as barbiturates, rifampicin, rifabutin, carbamazepine, phenytoin, primidone, and aminoglutethimide; or patients taking hepatic enzyme-inhibiting drugs, such as erythromycin and ketoconazole; （14）Patients undergoing chronic hemodialysis or with severe renal insufficiency (glomerular filtration rate \< 30 ml/min or serum creatinine \> 220 μmol/L (2.5 mg/dl)); （15）Systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg that is uncontrollable with oral antihypertensive drugs; （16）Blood glucose \< 2.8 mmol/L or \> 22.2 mmol/L; （17）Patients who have received a vaccine injection within the past month or have a plan for vaccination; （18）Patients who cannot understand or are unwilling to complete follow-up evaluations in accordance with the clinical study protocol; （19）Patients with advanced diseases with an expected life expectancy of \< 6 months; （20）Patients currently participating in other clinical trials.

Locations (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China