Clinical trial NCT06360458: Methylprednisolone Adjunctive to Endovascular Treatment for Stroke
Official title: Methylprednisolone in Adjunctive to Endovascular Treatment for Patients With Acute Ischemic Strokes With Established Large Infarct: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial (MIRACLE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Ischemic Stroke
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 902
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* The time from onset to randomization was within 12 hours.
* 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 (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.
* Planned treatment with endovascular therapy (EVT).
* Informed consent obtained from patients or their legal representatives.

Exclusion Criteria:

* 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 cannot 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.
* 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.

Primary outcomes:
measure: Primary Efficacy Outcome: Mortality at 90±7 days
timeFrame: Baseline-90 (±7) days
measure: Primary Safety Outcome: Proportion of patients with symptomatic intracranial haemorrhage (SICH) within 48 hours.
timeFrame: Baseline-48 hours
Secondary outcomes:
measure: mRS score improvement at 90 ±7 days
timeFrame: Baseline-90 (±7) days
measure: Proportion of patients with mRS score 0 to 4 at 90 ±7 days
timeFrame: Baseline-90 (±7) days
measure: Proportion of patients with mRS score 0 to 3 at 90 ±7 days
timeFrame: Baseline-90 (±7) days
measure: Proportion of patients with mRS score 0 to 2 at 90 ±7 days
timeFrame: Baseline-90 (±7) days
measure: Proportion of patients with mRS score 0 to 1 at 90 ±7 days
timeFrame: Baseline-90 (±7) days
measure: mRS score improvement at 1 year
timeFrame: Baseline-1 year
measure: Proportion of patients with mRS score 0 to 2 at 1 year
timeFrame: Baseline-1 year
measure: Proportion of patients with mRS score 0 to 1 at 1 year
timeFrame: Baseline-1 year
measure: mRS score improvement at 5 years
timeFrame: Baseline-5 years
measure: Proportion of patients with mRS score 0 to 2 at 5 years
timeFrame: Baseline-5 years
measure: Proportion of patients with mRS score 0 to 1 at 5 years
timeFrame: Baseline-5 years
measure: NIHSS score at 5-7 days or at early discharge
timeFrame: Baseline- 5-7 days ( or at early discharge)
measure: EQ-5D VAS at 90 ±7 days
timeFrame: Baseline-90 (±7) days
measure: Proportion of patients with malignant cerebral edema within 48 hours after EVT
timeFrame: Baseline-48 hours
measure: Proportion of patients with secondary decompressive craniectomy
timeFrame: From date of randomization until the date of discharge, an average of 1 week
measure: EQ-5D VAS at 1 year
timeFrame: Baseline-1 year
measure: EQ-5D VAS at 5 years
timeFrame: Baseline-5 years
measure: Proportion of patients with asymptomatic intracranial haemorrhage (aSICH) within 48 hours after EVT
timeFrame: Baseline-48 hours
measure: Incidence of any adverse events
timeFrame: From date of randomization until the date of end of trial, up to 90days
measure: Incidence of any complications
timeFrame: From date of randomization until the date of discharge, an average of 1 week
measure: Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT
timeFrame: Baseline-7 days
measure: Proportion of patients with pneumonia
timeFrame: From date of randomization until the date of discharge, an average of 1 week
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Neurology, First Affiliated Hospital Fujian Medical University
state: Fujian
Study officials:
References: