NCT07353749

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
864

participants targeted

Target at P75+ for phase_4

Timeline
14mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Jan 2026Sep 2027

First Submitted

Initial submission to the registry

January 6, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

January 6, 2026

Last Update Submit

January 17, 2026

Conditions

Cerebrovascular EventHemorrhagic StrokeMethylprednisoloneFlow DiverterUnruptured Intracranial Aneurysms

Keywords

Flow-diverter devicesIntracranial aneurysmMethylprednisoloneCerebrovascular Event

Outcome Measures

Primary Outcomes (1)

  • 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%.

    From the implantation procedure (Day 1) up to 30 days post-procedure (assessed at visits V2 to V5).

Secondary Outcomes (8)

  • Incidence of Any Cerebrovascular Adverse Event

    Within 72 hours (V2), at Postoperative Day 5 or early discharge (V3/V4), and within 30 days (V5).

  • Incidence of Any Ischemic Brain Event

    Within 72 hours (V2), at Postoperative Day 5 or early discharge (V3/V4), and within 30 days (V5).

  • Incidence of Any Hemorrhagic Brain Event

    Within 72 hours (V2), at Postoperative Day 5 or early discharge (V3/V4), and within 30 days (V5).

  • Functional Outcome - mRS Score Distribution

    At 30 days post-procedure (V5).

  • Incidence of Transient Ischemic Attack (TIA) within 72 hours

    Within 72 hours post-procedure (V2).

  • +3 more secondary outcomes

Study Arms (2)

Methylprednisolone Group

EXPERIMENTAL

Participants in this group will receive the investigational drug Methylprednisolone (injectable formulation) in addition to the standard therapy for flow-diverting device implantation. The specific administration regimen is as follows: Starting preoperatively on the day of surgery (Day 1), Methylprednisolone will be administered intravenously (IV drip at 40-60 drops per minute) once daily (qd) for 3 consecutive days. The dose is 2 mg per kilogram of body weight (with a maximum single daily dose not exceeding 160 mg), dissolved in normal saline.

Drug: Methylprednisolone (Injectable Form)

Placebo Control Group

PLACEBO COMPARATOR

Participants in this group will receive a placebo that is identical in appearance, volume, and mode of administration to the investigational drug, in addition to the identical standard therapy. Its administration regimen-including the start time, drip rate, duration, and treatment course-is fully matched to that of the Experimental Group to rigorously maintain the double.

Drug: Placebo Injection

Interventions

Placebo InjectionDRUG

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.

Placebo Control Group
Methylprednisolone (Injectable Form)DRUG

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

Methylprednisolone Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • （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.

You may not qualify if:

  • （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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China 510280, China

Location

MeSH Terms

Conditions

Hemorrhagic StrokeIntracranial Aneurysm

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial Arterial DiseasesAneurysm

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Chuanzhi Duan

    Southern Medical University, China

    STUDY DIRECTOR

Central Study Contacts

Chuanzhi Duan

CONTACT

02062782757doctor_duanzj@163.com

Xin Feng

CONTACT

1368113400113681134001@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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. Investigators, other blinded investigators, subjects, and sponsors will not have access to any information regarding group assignment or related documents pertaining to the trial drug.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 20, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

CN(1)