Methylprednisolone Adjunctive to Endovascular Thrombectomy for Stroke
- Conditions
- Acute Ischemic Stroke
- Interventions
- Drug: Placebo (normal saline)
- 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
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 928
- Age ≥ 18 years.
- The time from onset to randomization was within 12 hours.
- Anterior circulation ischemic stroke was preliminarily determined according to clinical symptoms or imaging examination.
- Occlusion of the intracranial internal carotid artery, the M1- or M2-segment of the middle cerebral artery by confirmed by CT angiography (CTA), MR angiography (MRA), or digital subtraction angiography (DSA).
- Baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 6.
- Baseline Alberta Stroke Program Early CT Score (ASPECTS) < 6 (based on non-contrast CT or MRI) or core infarct volume ≥ 50 ml (based on CTP with rCBF < 30%).
- Planned treatment with endovascular thrombectomy (EVT).
- Informed consent obtained from patients or their legal representatives.
- Intracranial hemorrhage confirmed by cranial CT or MRI.
- mRS score > 2 before onset.
- Pregnant or lactating women.
- Allergic to contrast agents or glucocorticoids.
- Participating in other clinical trials.
- The artery is tortuous so that the thrombectomy device cannot reach the target vessel.
- Bleeding history (gastrointestinal and urinary tract bleeding) in recent 1 month.
- 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.
- Systemic infectious disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebo (normal saline) Methylprednisolone sodium succinate simulant (normal saline placebo)
- Primary Outcome Measures
Name Time Method All-cause mortality at 90 (±14) days From randomization to 90 (±14) 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.
- Secondary Outcome Measures
Name Time Method Time from randomization to the occurrence of death from any cause at 90 (±14) days From randomization to 90 (±14) days Secondary Efficacy Outcome; To evaluate death rate of the two treatment groups
mRS ordinal shift at 90 (±14) days (scores 5 and 6 were merged) From randomization to 90 (±14) days Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 4 at 90 (±14) days From randomization to 90 (±14) days Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 3 at 90 (±14) days From randomization to 90 (±14) days Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 2 at 90 (±14) days or return to pre-stroke mRS score (for patients with pre-stroke mRS = 2) From randomization to 90 (±14) days Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 1 at 90 (±14) days or return to pre-stroke mRS score (for patients with pre-stroke mRS = 1) From randomization to 90 (±14) days Secondary Efficacy Outcome
Proportion of patients with midline shift within 48 hours after EVT From randomization to 48 hours Secondary Efficacy Outcome
Proportion of patients with decompressive craniectomy after EVT From randomization until the date of discharge, an average of 1 week Secondary Efficacy Outcome
NIHSS score at 5-7 days or at early discharge From randomization to 5-7 days ( or at early discharge) Secondary Efficacy Outcome
EQ-5D-5L VAS at 90 (±14) days From randomization to 90 (±14) days Secondary Efficacy Outcome
Proportion of patients with symptomatic intracranial haemorrhage (SICH) within 48 hours after EVT From randomization to 48 hours Primary Safety Outcome. Based on the modified Heidelberg Bleeding Classification.
Proportion of patients with any intracranial haemorrhage (ICH) within 48 hours after EVT From randomization to 48 hours Secondary Safety Outcome. Based on the modified Heidelberg Bleeding Classification.
Proportion of patients with pneumonia From 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 From randomization to 7 days Secondary Safety Outcome
Incidence of any complications From date of randomization until the date of discharge, an average of 1 week Secondary Safety Outcome
Incidence of any (serious) adverse events From randomization to 90 (±14) days Secondary Safety Outcome
Trial Locations
- Locations (98)
The First Affiliated Hospital of USTC
🇨🇳Hefei, Anhui, China
Hefei First People's Hospital
🇨🇳Hefei, Anhui, China
Taihe County People's Hospital
🇨🇳Taihe, Anhui, China
Yijishan Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Anxi County Hospital
🇨🇳Anxi, Fujian, China
Anxi Hospital of Traditional Chinese Medicine
🇨🇳Anxi, Fujian, China
Fuqing City Hospital of Fujian
🇨🇳Fuqing, Fujian, China
Fuzhou University Affiliated Provincial Hospital
🇨🇳Fuzhou, Fujian, China
Union Hospital Affiliated to Fujian Medical University
🇨🇳Fuzhou, Fujian, China
The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine
🇨🇳Fuzhou, Fujian, China
Scroll for more (88 remaining)The First Affiliated Hospital of USTC🇨🇳Hefei, Anhui, China