A Phase 4 interventional study of Methylprednisolone (Injectable Form) and Placebo Injection in Unruptured Intracranial Aneurysms, Cerebrovascular Event and Hemorrhagic Stroke, sponsored by Duan Chuanzhi. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Duan Chuanzhi · Phase 4, Interventional, and Treatment
Peking Union Medical College Hospital · Deyang People's Hospital · Guizhou Provincial People's Hospital · First Affiliated Hospital of Xinjiang Medical University · Huangshi Central Hospital · Huizhou First Hospital · Maoming People's Hospital · First Affiliated Hospital of Ningbo University · Quanzhou First Hospital · Shanxi Cardiovascular Hospital · Shaoxing People's Hospital · Shenzhen Second People's Hospital · Tianjin Huanhu Hospital · Wuhan Central Hospital · The Affiliated Hospital of Xuzhou Medical University · Yongzhou Central Hospital · The First People's Hospital of Zunyi
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 all-cause death 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, aneurysm located in the posterior circulation, 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 all-cause 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 December 2028.
Who is organizing the study? This study is sponsored and led by Zhujiang Hospital, Southern Medical University.
Flow-diverting devices (FDs) are widely used for the endovascular treatment of unruptured intracranial aneurysms (UIAs). By redirecting blood flow away from the aneurysm sac, FDs promote intra-aneurysmal thrombosis and subsequent endothelial remodeling, facilitating aneurysm occlusion and parent artery reconstruction. However, ischemic and hemorrhagic cerebrovascular complications remain important concerns following FD implantation, highlighting the need for effective perioperative strategies to improve procedural safety.
The biological processes following FD implantation involve complex interactions among intra-aneurysmal thrombosis, vascular injury, and inflammatory responses. These inflammatory processes may contribute to postprocedural cerebrovascular complications. Methylprednisolone, a glucocorticoid with potent anti-inflammatory effects, may attenuate perioperative inflammatory responses and potentially reduce the risk of adverse cerebrovascular events. Preliminary observational evidence from our research group has suggested an association between perioperative glucocorticoid administration and a lower incidence of cerebrovascular adverse events following FD implantation. However, the nonrandomized nature of these findings limits causal inference, and the efficacy and safety of this treatment strategy require further evaluation in a randomized controlled trial.
This multicenter, randomized, double-blind, placebo-controlled trial is designed to investigate whether short-term perioperative methylprednisolone administration reduces the risk of new stroke or all-cause death within 30 days following FD implantation in patients with UIAs. The study will also evaluate early cerebrovascular complications, neurological and functional outcomes, and treatment-related adverse events to comprehensively assess the potential benefits and risks of methylprednisolone treatment.
The findings of this trial are expected to provide high-quality clinical evidence regarding the efficacy and safety of perioperative methylprednisolone and help inform future perioperative management strategies for patients undergoing FD treatment.
233 studies on the registry are indexed under Hemorrhagic Stroke; 93 are open to participants now.
This study's planned enrollment of 864 is above the median of 58 across 156 interventional studies indexed under Hemorrhagic Stroke.
Browse Hemorrhagic Stroke studies →Duan Chuanzhi is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 26, 2026. See what changed
**Inclusion Criteria:**
**Exclusion Criteria:**
Any of the following glucose abnormalities:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this group will receive methylprednisolone sodium succinate for injection in addition to standard flow-diverter treatment and routine perioperative management. Methylprednisolone sodium succinate will be administered intravenously at a dose of 2 mg/kg once daily, with a maximum daily dose of 160 mg, for 3 consecutive days. The first dose will be initiated preoperatively on the day of flow-diverter implantation (Day 1). The study drug will be dissolved in 100 mL of normal saline and administered by intravenous infusion at approximately 40-60 drops per minute.
Drug: Methylprednisolone (Injectable Form)
Participants assigned to this group will receive a matched placebo in addition to the same standard flow-diverter treatment and routine perioperative management. The placebo is matched to methylprednisolone sodium succinate for injection in appearance and packaging and will be administered according to the same schedule and administration procedure as the active treatment: once daily for 3 consecutive days, beginning preoperatively on the day of flow-diverter implantation (Day 1).
Drug: Placebo Injection
Methylprednisolone sodium succinate for injection will be administered intravenously at a dose of 2 mg/kg once daily, with a maximum daily dose of 160 mg, for 3 consecutive days. The first dose will be initiated preoperatively on the day of flow-diverter implantation (Day 1). The study drug will be dissolved in 100 mL of normal saline and administered by intravenous infusion at approximately 40-60 drops per minute.
A matched placebo, identical in appearance and packaging to methylprednisolone sodium succinate for injection, will be administered intravenously according to the same schedule and administration procedure as the active treatment: once daily for 3 consecutive days, beginning preoperatively on the day of flow-diverter implantation (Day 1).
Incidence of Any New Stroke or All-Cause Death Within 30 Days
The primary outcome is a composite endpoint of any new ischemic stroke, hemorrhagic stroke, or all-cause death occurring within 30 days after flow-diverter implantation. Ischemic stroke is defined as a new-onset focal acute neurological deficit lasting at least 24 hours, with cerebral infarction confirmed by computed tomography (CT) or magnetic resonance imaging (MRI). Hemorrhagic stroke is defined as subarachnoid, intraparenchymal, or intraventricular hemorrhage identified on CT or MRI and associated with new neurological symptoms lasting more than 24 hours, including altered level of consciousness, headache, or focal neurological symptoms, or resulting in seizure. Intracranial hemorrhage will be classified according to the Heidelberg Bleeding Classification. All-cause death is defined as death from any cause.
Time frame: From the day of flow-diverter implantation through 30 days post-procedure; outcome status will be assessed within 24 hours, within 72 hours, at postoperative Day 5 or discharge, and at the 30-day follow-up visit (30 ± 7 days).
Incidence of Any Cerebral Ischemic Event Within 72 Hours, at Day 5/Discharge, and Within 30 Days
Any cerebral ischemic event includes ischemic stroke, transient ischemic attack (TIA), in-stent thrombosis, or emergency revascularization. The outcome will be reported as the number and proportion of participants experiencing at least one qualifying event.
Time frame: Within 72 hours after the procedure; at postoperative Day 5 or discharge; and through 30 days post-procedure.
Incidence of In-Stent Thrombosis Within 30 Days
In-stent thrombosis is defined as thrombus formation at the stent implantation site confirmed by digital subtraction angiography (DSA). The outcome will be reported as the number and proportion of participants meeting this definition.
Time frame: From the flow-diverter implantation procedure through 30 days post-procedure.
Incidence of Emergency Revascularization Within 30 Days
Emergency revascularization is defined as acute occlusion of the target vessel associated with neurological deficits and requiring intravenous thrombolysis, intra-arterial thrombolysis, mechanical thrombectomy, or balloon/stent angioplasty. The outcome will be reported as the number and proportion of participants meeting this definition.
Time frame: From the flow-diverter implantation procedure through 30 days post-procedure.
Incidence of Any Cerebral Hemorrhagic Event Within 72 Hours, at Day 5/Discharge, and Within 30 Days
Any cerebral hemorrhagic event includes intraparenchymal hemorrhage, subarachnoid hemorrhage, or subdural hematoma. The outcome will be reported as the number and proportion of participants experiencing at least one qualifying event.
Time frame: Within 72 hours after the procedure; at postoperative Day 5 or discharge; and through 30 days post-procedure.
All-Cause Mortality Within 30 Days
Death from any cause occurring within 30 days after flow-diverter implantation. The outcome will be reported as the number and proportion of participants who die from any cause.
Time frame: From the flow-diverter implantation procedure through 30 days post-procedure.
Proportion of Participants With Modified Rankin Scale Score 0-2 at 30 Days
The modified Rankin Scale (mRS) assesses global disability on a 7-point scale ranging from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability. The proportion of participants with an mRS score of 0-2 will be reported.
Time frame: At the 30-day follow-up visit (30 ± 7 days).
Proportion of Participants With Modified Rankin Scale Score 3-5 at 30 Days
The modified Rankin Scale (mRS) assesses global disability on a 7-point scale ranging from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability. The proportion of participants with an mRS score of 3-5 will be reported.
Time frame: At the 30-day follow-up visit (30 ± 7 days).
Incidence of Transient Ischemic Attack Within 72 Hours, at Day 5, and Within 30 Days
Transient ischemic attack (TIA) is defined as transient neurological dysfunction caused by temporary interruption of cerebral blood flow, with complete resolution of symptoms within 24 hours and no corresponding acute cerebral infarction identified on imaging. The outcome will be reported as the number and proportion of participants experiencing TIA.
Time frame: Within 72 hours after the procedure; at postoperative Day 5; and through 30 days post-procedure.
EQ-5D Health-Related Quality-of-Life Score at 30 Days
The EQ-5D assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. EQ-5D-derived health utility and self-rated health measures will be assessed and reported.
Time frame: At the 30-day follow-up visit (30 ± 7 days).
Incidence of New Moderate or Severe Adverse Events Within 30 Days
New moderate or severe adverse events include any of the following: serious infection requiring hospitalization; new-onset diabetes; clinically significant gastrointestinal bleeding requiring hospitalization; clinically significant fracture or osteonecrosis; cardiovascular events including myocardial infarction, heart failure, or death due to another cardiovascular disease; or other events meeting the protocol-defined criteria for moderate or severe adverse events. The outcome will be reported as the number and proportion of participants experiencing at least one qualifying event.
Time frame: Within 72 hours after the procedure; at postoperative Day 5; and through 30 days post-procedure.
Incidence of Intracranial Hemorrhage Within 72 Hours After Study Treatment
The number and proportion of participants experiencing any intracranial hemorrhage within 72 hours after study treatment will be reported.
Time frame: Within 72 hours after study treatment.
Incidence of Systemic Bleeding Complications Within 30 Days
Systemic bleeding complications include gastrointestinal bleeding and generalized subcutaneous bleeding. The number and proportion of participants experiencing a systemic bleeding complication will be reported.
Time frame: From the flow-diverter implantation procedure through 30 days post-procedure.
Incidence of Non-Hemorrhagic Serious Adverse Events Within 30 Days
The number and proportion of participants experiencing a serious adverse event other than a hemorrhagic event will be reported according to the protocol-defined criteria for serious adverse events.
Time frame: From the flow-diverter implantation procedure through 30 days post-procedure.
Incidence of Gastrointestinal Bleeding Through Postoperative Day 5 or Discharge
The number and proportion of participants experiencing gastrointestinal bleeding through postoperative Day 5 or hospital discharge will be reported. New gastrointestinal bleeding events occurring after discharge will additionally be ascertained at the 30-day follow-up.
Time frame: From the day of the procedure through postoperative Day 5 or hospital discharge; post-discharge events will additionally be ascertained through 30 days post-procedure.
Incidence of Pulmonary Infection During Hospitalization
Pulmonary infection is defined as a clinically diagnosed pulmonary infection requiring antibiotic treatment during hospitalization. The outcome will be reported as the number and proportion of participants meeting this definition.
Time frame: During hospitalization, from the day of the procedure through hospital discharge.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2028, 24 months later.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 26, 2026: start Jan 2026 → Nov 2026, primary completion Aug 2027 → Dec 2028 and completion Sep 2027 → Dec 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
Peking Union Medical College Hospital · Deyang People's Hospital · Guizhou Provincial People's Hospital · First Affiliated Hospital of Xinjiang Medical University · Huangshi Central Hospital · Huizhou First Hospital · Maoming People's Hospital · First Affiliated Hospital of Ningbo University · Quanzhou First Hospital · Shanxi Cardiovascular Hospital · Shaoxing People's Hospital · Shenzhen Second People's Hospital · Tianjin Huanhu Hospital · Wuhan Central Hospital · The Affiliated Hospital of Xuzhou Medical University · Yongzhou Central Hospital · The First People's Hospital of Zunyi
Peking Union Medical College Hospital · Deyang People's Hospital · Guizhou Provincial People's Hospital · First Affiliated Hospital of Xinjiang Medical University · Huangshi Central Hospital · Huizhou First Hospital · Maoming People's Hospital · First Affiliated Hospital of Ningbo University · Quanzhou First Hospital · Shanxi Cardiovascular Hospital · Shaoxing People's Hospital · Shenzhen Second People's Hospital · Tianjin Huanhu Hospital · Wuhan Central Hospital · The Affiliated Hospital of Xuzhou Medical University · Yongzhou Central Hospital · The First People's Hospital of Zunyi
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methylprednisolone