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Active, Not Recruiting

NCT Number: NCT06360458

Methylprednisolone Adjunctive to Endovascular Thrombectomy for Stroke

The efficacy and safety of methylprednisolone in acute ischemic stroke patients with large infarct cores (ASPECTS score < 6 or infarct volume ≥50 mL) 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Large Infarct Core Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hefei First People's Hospital, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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) and/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.

Exclusion criteria

  • 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.

Treatment and study plan

Methylprednisolone Sodium Succinate

Drug

Intravenous injection of methylprednisolone sodium succinate (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.

Placebo

Drug

Intravenous injection of placebo (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.

Primary outcomes

  1. All-cause mortality at 90 (±14) days

    Time frame: 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 outcomes

  1. Time from randomization to the occurrence of death from any cause at 90 (±14) days

    Time frame: From randomization to 90 (±14) days

    Secondary Efficacy Outcome; To evaluate death rate of the two treatment groups

  2. mRS ordinal shift at 90 (±14) days (scores 5 and 6 are merged)

    Time frame: From randomization to 90 (±14) days

    Secondary Efficacy Outcome

  3. Proportion of patients with mRS score 0 to 4 at 90 (±14) days

    Time frame: From randomization to 90 (±14) days

    Secondary Efficacy Outcome

  4. Proportion of patients with mRS score 0 to 3 at 90 (±14) days

    Time frame: From randomization to 90 (±14) days

    Secondary Efficacy Outcome

  5. Proportion of patients with mRS score 0 to 2 at 90 (±14) days

    Time frame: From randomization to 90 (±14) days

    Secondary Efficacy Outcome

  6. 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)

    Time frame: From randomization to 90 (±14) days

    Secondary Efficacy Outcome

  7. Midline shift at 48 hours

    Time frame: From randomization to 48 hours

    Secondary Efficacy Outcome

  8. Proportion of patients with midline shift >5 mm within 48 hours after EVT

    Time frame: From randomization to 48 hours

    Secondary Efficacy Outcome

  9. Relative hemispheric volume at 48 hours

    Time frame: From randomization to 48 hours

    Secondary Efficacy Outcome.

  10. Net water uptake at 48 hours

    Time frame: From randomization to 48 hours

    Secondary Efficacy Outcome

  11. Proportion of patients with decompressive craniectomy after EVT

    Time frame: From randomization until the date of discharge, an average of 1 week

    Secondary Efficacy Outcome

  12. NIHSS score at 5-7 days or at early discharge

    Time frame: From randomization to 5-7 days ( or at early discharge)

    Secondary Efficacy Outcome

  13. EQ-5D-5L VAS at 90 (±14) days

    Time frame: From randomization to 90 (±14) days

    Secondary Efficacy Outcome

  14. Proportion of patients with symptomatic intracranial haemorrhage (SICH) within 48 hours after EVT

    Time frame: From randomization to 48 hours

    Primary Safety Outcome. Based on the modified Heidelberg Bleeding Classification.

  15. Proportion of patients with any intracranial haemorrhage (ICH) within 48 hours after EVT

    Time frame: From randomization to 48 hours

    Secondary Safety Outcome. Based on the modified Heidelberg Bleeding Classification.

  16. Proportion of patients with pneumonia

    Time frame: From randomization until the date of discharge, an average of 1 week

    Secondary Safety Outcome

  17. Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT

    Time frame: From randomization to 7 days

    Secondary Safety Outcome

  18. Incidence of any complications

    Time frame: From date of randomization until the date of discharge, an average of 1 week

    Secondary Safety Outcome

  19. Incidence of any (serious) adverse events

    Time frame: From randomization to 90 (±14) days

    Secondary Safety Outcome

Other outcomes

  1. mRS ordinal shift at 1 year (scores 5 and 6 are merged)

    Time frame: From randomization to 1 year

    Tertiary Efficacy Outcome

  2. Proportion of patients with mRS score 0 to 2 at 1 year

    Time frame: From randomization to 1 year

    Tertiary Efficacy Outcome

  3. 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)

    Time frame: From randomization to 1 year

    Tertiary Efficacy Outcome

  4. mRS ordinal shift at 5 years (scores 5 and 6 are merged)

    Time frame: From randomization to 5 years

    Tertiary Efficacy Outcome

  5. Proportion of patients with mRS score 0 to 2 at 5 years

    Time frame: From randomization to 5 years

    Tertiary Efficacy Outcome

  6. Proportion of patients with mRS score 0 to 1 at 5 years or return to pre-stroke mRS score (for patients with pre-stroke mRS > 1)

    Time frame: From randomization to 5 years

    Tertiary Efficacy Outcome

  7. EQ-5D-5L VAS at 1 year

    Time frame: From randomization to 1 year

    Tertiary Efficacy Outcome

  8. EQ-5D-5L VAS at 5 years

    Time frame: From randomization to 5 years

    Tertiary Efficacy Outcome

Sponsors and collaborators

Lead sponsor

Wan-Jin Chen

Other

Registry information

Official study title

Methylprednisolone as Adjunct to Endovascular Thrombectomy for Patients With Acute Ischemic Strokes With Large Infarct: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial (MIRACLE)

Acronym: MIRACLE

Important dates

Study start
2024
Primary completion
2025
Study completion
2030
First posted
Apr 11, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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