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
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 864
研究概览
简要总结
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.
详细描述
Title: A Study on the Efficacy and Safety of Methylprednisolone in Preventing Cerebrovascular Adverse Events after Flow-Diverting Device Implantation in Patients with Unruptured Intracranial Aneurysms-A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Sponsor: Zhujiang Hospital, Southern Medical University Leading Institution: Zhujiang Hospital, Southern Medical University
Research Objectives:
Primary Objective: To evaluate the efficacy of methylprednisolone treatment on the composite outcome of any new cerebrovascular adverse event and neurologic death within 30 days after flow-diverting device implantation in patients with unruptured intracranial aneurysms (IAs).
Secondary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The subject numbers and corresponding medication numbers are permanently identified and unique for each successfully randomized patient. If any patients who have been successfully randomized do not receive the trial medication or cannot be reassigned to others, their medication and medication numbers will be invalidated by the medication administrator. To ensure blinding during the trial execution, unblinded personnel responsible for administering and configuring the trial drug must sign a confidentiality agreement.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •（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.
排除标准
- •（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.
研究者
Duan Chuanzhi
Professor
Zhujiang Hospital