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The efficacy and safety of early adjunctive methylprednisolone therapy in acute ischemic stroke patients with large infarct cores (ASPECTS score < 6) and post-stroke lymphocytopenia remain unclear. These immunocompromised patients face higher mortality rates and poorer clinical outcomes, with limited effective treatment options currently available. This multicenter, randomized, double-blind, placebo-controlled, non-inferiority trial aims to demonstrate that early methylprednisolone administration combined with reperfusion therapy is non-inferior to placebo in terms of survival and functional outcomes at 90 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone sodium succinate group | Experimental |
| |
| Methylprednisolone sodium succinate simulant (normal saline placebo) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone sodium succinate | Drug | Methylprednisolone sodium succinate Intravenous injection of methylprednisolone sodium succinate (Chongqing Lummy Pharmaceutical Co., Ltd., 40mg/ vial) with a dose of 2mg/kg (maximum dose of 160mg), once daily, for three consecutive days. The initial study drug will be administered as soon as possible after randomization. It is recommended that the initial study drug administrated before arterial access closure, but it should not be delayed more than 2 hours after arterial access closure. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality at 90 (±7) days | Primary Efficacy Outcome. Defined as the number of any cause deaths observed divided by the number of subjects observed over the 90-day study period. | From randomization to 90 (±7) days |
| Measure | Description | Time Frame |
|---|---|---|
| Time from randomization to the occurrence of death from any cause at 90 (±7) days | Secondary Efficacy Outcome; To evaluate death rate of the two treatment groups | From randomization to 90 (±7) days |
| mRS ordinal shift at 90 (±7) days (scores 5 and 6 are merged) |
| Measure | Description | Time Frame |
|---|---|---|
| mRS ordinal shift at 1 year (scores 5 and 6 are merged) | Tertiary Efficacy Outcome | From randomization to 1 year |
| Proportion of patients with mRS score 0 to 2 at 1 year | Tertiary Efficacy Outcome |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Lin, MD | Contact | 86-13615039153 | linyi7811@163.com | |
| Ying Fu, MD | Contact | 86-13920263588 | fuying1995@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, the First Affiliated Hospital Fujian Medical University | Recruiting | Fuzhou | Fujian | 350005 | China |
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| ID | Term |
|---|---|
| D008776 | Methylprednisolone Hemisuccinate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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|
| Normal Saline | Drug | Intravenous injection of placebo (normal saline) (Chongqing Lummy Pharmaceutical Co., Ltd., 40mg/ bottle) with a dose of 2mg/kg (maximum dose of 160mg), once daily, for three consecutive days. The initial study drug will be administered as soon as possible after randomization. It is recommended that the initial study drug administrated before arterial access closure, but it should not be delayed more than 2 hours after arterial access closure. |
|
Secondary Efficacy Outcome |
| From randomization to 90 (±7) days |
| Proportion of patients with mRS score 0 to 4 at 90 (±7) days | Secondary Efficacy Outcome | From randomization to 90 (±7) days |
| Proportion of patients with mRS score 0 to 3 at 90 (±7) days | Secondary Efficacy Outcome | From randomization to 90 (±7) days |
| Proportion of patients with mRS score 0 to 2 at 90 (±7) days | Secondary Efficacy Outcome | From randomization to 90 (±7) days |
| Proportion of patients with mRS score 0 to 1 at 90 (±7) days or return to pre-stroke mRS score (for patients with prestroke mRS > 1) | Secondary Efficacy Outcome | From randomization to 90 (±7) days |
| Midline shift at 48 hours | Secondary Efficacy Outcome | From randomization to 48 hours |
| Proportion of patients with midline shift maximum > 5 mm within 48 hours (%) | Secondary Efficacy Outcome | From randomization to 48 hours |
| Relative hemispheric volume at 48 hours | Secondary Efficacy Outcome | From randomization to 48 hours |
| Net water uptake at 48 hours | Secondary Efficacy Outcome | From randomization to 48 hours |
| Proportion of patients with decompressive craniectomy after EVT | Secondary Efficacy Outcome | From randomization until the date of discharge, an average of 1 week |
| NIHSS score at 5-7 days or at early discharge | Secondary Efficacy Outcome | From randomization to 5-7 days (or at early discharge) |
| EQ-5D-5L VAS at 90 (±7) days | Secondary Efficacy Outcome | From randomization to 90 (±7) days |
| Proportion of patients with symptomatic intracranial haemorrhage (SICH) within 48 hours after EVT | Primary Safety Outcome. Based on the modified Heidelberg Bleeding Classification. | From randomization to 48 hours |
| Proportion of patients with any intracranial haemorrhage (ICH) within 48 hours after EVT | Secondary Safety Outcome. Based on the modified Heidelberg Bleeding Classification. | From randomization to 48 hours |
| Proportion of patients with pneumonia | Secondary Safety Outcome | From randomization until the date of discharge, an average of 1 week |
| Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT | Secondary Safety Outcome | From randomization to 7 days |
| Incidence of any complications | Secondary Safety Outcome | From date of randomization until the date of discharge, an average of 1 week |
| Incidence of any (serious) adverse events | Secondary Safety Outcome | From randomization to 90 (±7) days |
| From randomization to 1 year |
| Proportion of patients with mRS score 0 to 1 at 1 year or return to pre-stroke mRS score (for patients with pre-stroke mRS > 1) | Tertiary Efficacy Outcome | From randomization to 1 year |
| EQ-5D-5L VAS at 1 year | Tertiary Efficacy Outcome | From randomization to 1 year |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |