Methylprednisolone Adjunctive to Endovascular Treatment for Stroke
- Conditions
- Acute Ischemic Stroke
- Interventions
- Drug: Placebo (Methylprednisolone sodium succinate simulant)
- Registration Number
- NCT06360458
- Lead Sponsor
- Wan-Jin Chen
- Brief Summary
The efficacy and safety of methylprednisolone in acute ischemic stroke patients with large infarct cores (ASPECTS score \< 6) due to anterior circulation large vessel occlusion have not been clearly established. This is a multi-center, randomized, double-blind, placebo-controlled trial to investigate early combination therapy with methylprednisolone for reperfusion in acute large core infarction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 735
- Age ≥ 18 years.
- Presenting with AIS with symptoms within 12 hours from time last known well.
- Anterior circulation ischemic stroke was determined according to clinical symptoms and imaging examination.
- Occlusion of the intracranial internal carotid artery, the M1- or M2-segment of the middle cerebral artery confirmed by CT angiography, MR angiography, or digital subtraction angiography.
- Baseline National Institutes of Health Stroke Scale (NIHSS)≥6.
- Baseline Alberta Stroke Program Early CT Score (ASPECTS)<6.
- Planned treatment with endovascular therapy (EVT).
- Informed consent obtained from patients or their legal representatives.
- Intracranial hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI).
- mRS score >= 2 before onset.
- Pregnant or lactating women.
- Allergic to contrast agents or glucocorticoids.
- Participating in other clinical trials.
- Systolic blood pressure >185 mmHg or diastolic pressure >110 mmHg, and oral antihypertensive drugs can not control.
- Genetic or acquired bleeding constitution, lack of anticoagulant factors, or oral anticoagulants and INR > 1.7.
- Blood sugar < 2.8 mmol/L (50 mg/dl) or > 22.2 mmol/L (400 mg/dl), platelet < 90 x 10^9/L.
- The artery is tortuous so that the thrombectomy device cannot reach the target vessel.
- Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate < 30 ml/min or serum creatinine > 220 umol/L [2.5 mg/ dL]).
- Life expectancy due to any advanced disease < 6 months.
- Follow-up is not expected to be completed.
- Intracranial aneurysm and arteriovenous malformation.
- Brain tumors with imaging mass effect.
- Macular edema.
- Möbitz type II second-degree/third-degree atrioventricular block or sick sinus syndrome or medical history.
- Systemic infectious disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methylprednisolone sodium succinate group Methylprednisolone sodium succinate - Placebo group Placebo (Methylprednisolone sodium succinate simulant) Methylprednisolone sodium succinate simulant
- Primary Outcome Measures
Name Time Method Primary Efficacy Outcome: Mortality at 90±7 days Baseline-90 (±7) days Incidence of all-cause mortality at 90±7 days
Primary Safety Outcome: Proportion of patients with symptomatic intracranial haemorrhage (SICH) within 48 hours. Baseline-48 hours Symptomatic intracranial haemorrhage will be adjudicated by an independent Imaging Core Laboratory according to the modified Heidelberg Bleeding Classification
- Secondary Outcome Measures
Name Time Method mRS score improvement at 90 ±7 days Baseline-90 (±7) days Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 4 at 90 ±7 days Baseline-90 (±7) days Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 3 at 90 ±7 days Baseline-90 (±7) days Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 2 at 90 ±7 days Baseline-90 (±7) days Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 1 at 90 ±7 days Baseline-90 (±7) days Secondary Efficacy Outcome
mRS score improvement at 1 year Baseline-1 year Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 2 at 1 year Baseline-1 year Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 1 at 1 year Baseline-1 year Secondary Efficacy Outcome
mRS score improvement at 5 years Baseline-5 years Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 2 at 5 years Baseline-5 years Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 1 at 5 years Baseline-5 years Secondary Efficacy Outcome
NIHSS score at 5-7 days or at early discharge Baseline- 5-7 days ( or at early discharge) Secondary Efficacy Outcome
EQ-5D VAS at 90 ±7 days Baseline-90 (±7) days Secondary Efficacy Outcome
Proportion of patients with malignant cerebral edema within 48 hours after EVT Baseline-48 hours Secondary Efficacy Outcome
Proportion of patients with secondary decompressive craniectomy From date of randomization until the date of discharge, an average of 1 week Secondary Efficacy Outcome
EQ-5D VAS at 1 year Baseline-1 year Secondary Efficacy Outcome
EQ-5D VAS at 5 years Baseline-5 years Secondary Efficacy Outcome
Proportion of patients with asymptomatic intracranial haemorrhage (aSICH) within 48 hours after EVT Baseline-48 hours Secondary Safety Outcome
Incidence of any adverse events From date of randomization until the date of end of trial, up to 90days Secondary Safety Outcome
Incidence of any complications From date of randomization until the date of discharge, an average of 1 week Secondary Safety Outcome
Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT Baseline-7 days Secondary Safety Outcome
Proportion of patients with pneumonia From date of randomization until the date of discharge, an average of 1 week Secondary Safety Outcome
Trial Locations
- Locations (1)
Department of Neurology, First Affiliated Hospital Fujian Medical University
🇨🇳Fuzhou, Fujian, China