Using methylprednisolone with endovascular treatment for stroke

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)

This study is testing if adding a steroid called methylprednisolone to a common stroke treatment can help people with severe strokes recover better.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 902 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Fujian Medical University (other)
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06360458 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of methylprednisolone in patients suffering from acute ischemic stroke with large infarct cores. It is a multi-center, randomized, double-blind, placebo-controlled trial that aims to evaluate the effects of early combination therapy with methylprednisolone alongside endovascular treatment. Participants will be monitored for outcomes related to reperfusion and recovery following their stroke. The study focuses on patients with specific imaging and clinical criteria to ensure appropriate selection.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced an anterior circulation ischemic stroke within 12 hours and have specific imaging findings.

Not a fit: Patients with confirmed intracranial hemorrhage or those with significant pre-existing disability may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve recovery outcomes for patients with severe strokes caused by large vessel occlusions.

How similar studies have performed: While the use of methylprednisolone in stroke treatment has been explored, this specific combination therapy approach is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Fuzhou, Fujian

• Department of Neurology, First Affiliated Hospital Fujian Medical University — Fuzhou, Fujian, China (RECRUITING)

Study contacts

• Study coordinator: Wan-Jin Chen, MD

Conditions: Acute Ischemic Stroke