Recruiting

NCT Number: NCT07202143

Methylprednisolone for Stroke With Large Infarct Core and Post-stroke Lymphocytopenia

The efficacy and safety of early adjunctive methylprednisolone therapy in acute ischemic stroke patients with large infarct cores (ASPECTS score < 6) and post-stroke lymphocytopenia remain unclear. These immunocompromised patients face higher mortality rates and poorer clinical outcomes, with limited effective treatment options currently available. This multicenter, randomized, double-blind, placebo-controlled, non-inferiority trial aims to demonstrate that early methylprednisolone administration combined with reperfusion therapy is non-inferior to placebo in terms of survival and functional outcomes at 90 days.

Recruiting

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Key information

Conditions

Large Infarct Core Post-stroke Lymphocytopenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Neurology, the First Affiliated Hospital Fujian Medical University

Fuzhou, Fujian, 350005, China

Location status: Recruiting

Location contact

Wanjin Chen, MD

SUB_INVESTIGATOR

Yi Lin, MD

CONTACT

[email protected]

13615039153

Yi Lin, MD

PRINCIPAL_INVESTIGATOR

Ying Fu, MD

SUB_INVESTIGATOR

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 last known well to randomization was within 24 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).
Baseline peripheral blood lymphocyte < 0.8×10#/L
Informed consent obtained from patients or their legal representatives.

Exclusion criteria

Intracranial hemorrhage confirmed by cranial CT or MRI.
mRS score > 2 before the time of last known well.
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

Methylprednisolone sodium succinate Intravenous injection of methylprednisolone sodium succinate (Chongqing Lummy Pharmaceutical Co., Ltd., 40mg/ vial) 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.

normal saline

Drug

Intravenous injection of placebo (normal saline) (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

All-cause mortality at 90 (±7) days

Time frame: From randomization to 90 (±7) 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

Time from randomization to the occurrence of death from any cause at 90 (±7) days

Time frame: From randomization to 90 (±7) days

Secondary Efficacy Outcome; To evaluate death rate of the two treatment groups
mRS ordinal shift at 90 (±7) days (scores 5 and 6 are merged)

Time frame: From randomization to 90 (±7) days

Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 4 at 90 (±7) days

Time frame: From randomization to 90 (±7) days

Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 3 at 90 (±7) days

Time frame: From randomization to 90 (±7) days

Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 2 at 90 (±7) days

Time frame: From randomization to 90 (±7) days

Secondary Efficacy Outcome
Proportion of patients with mRS score 0 to 1 at 90 (±7) days or return to pre-stroke mRS score (for patients with prestroke mRS > 1)

Time frame: From randomization to 90 (±7) days

Secondary Efficacy Outcome
Midline shift at 48 hours

Time frame: From randomization to 48 hours

Secondary Efficacy Outcome
Proportion of patients with midline shift maximum > 5 mm within 48 hours (%)

Time frame: From randomization to 48 hours

Secondary Efficacy Outcome
Relative hemispheric volume at 48 hours

Time frame: From randomization to 48 hours

Secondary Efficacy Outcome
Net water uptake at 48 hours

Time frame: From randomization to 48 hours

Secondary Efficacy Outcome
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
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
EQ-5D-5L VAS at 90 (±7) days

Time frame: From randomization to 90 (±7) days

Secondary Efficacy Outcome
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.
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.
Proportion of patients with pneumonia

Time frame: 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

Time frame: From randomization to 7 days

Secondary Safety Outcome
Incidence of any complications

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

Secondary Safety Outcome
Incidence of any (serious) adverse events

Time frame: From randomization to 90 (±7) days

Secondary Safety Outcome

Other outcomes

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

Time frame: From randomization to 1 year

Tertiary Efficacy Outcome
Proportion of patients with mRS score 0 to 2 at 1 year

Time frame: From randomization to 1 year

Tertiary Efficacy Outcome
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
EQ-5D-5L VAS at 1 year

Time frame: From randomization to 1 year

Tertiary Efficacy Outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Lin, MD

CONTACT

[email protected]

86-13615039153

Ying Fu, MD

CONTACT

[email protected]

86-13920263588

Sponsors and collaborators

Lead sponsor

YiLin

Other

Registry information

Official study title

Methylprednisolone as Adjunct to Endovascular Thrombectomy for Acute Ischemic Stroke With Large Infarct Core and Post-stroke Lymphocytopenia -A Multicenter, Randomized, Double-blind, Placebo-controlled, Non-inferiority Trial

Acronym: MIRACLE-2

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Oct 1, 2025
Registry last updated: Oct 1, 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.

Published trials that share one or more normalized conditions with this study.

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Methylprednisolone Adjunctive to Endovascular Thrombectomy for Stroke

NCT06360458

Acute Ischemic Stroke, Brain Diseases

Hefei, Anhui, China

View Trial Details

Key information

Conditions

Age range

Sex eligibility

Study type

Phase

Primary location

Department of Neurology, the First Affiliated Hospital Fujian Medical University

Location contact

Who can participate

Treatment and study plan

Methylprednisolone Sodium Succinate

normal saline

Primary outcomes

All-cause mortality at 90 (±7) days

Secondary outcomes

Time from randomization to the occurrence of death from any cause at 90 (±7) days

mRS ordinal shift at 90 (±7) days (scores 5 and 6 are merged)

Proportion of patients with mRS score 0 to 4 at 90 (±7) days

Proportion of patients with mRS score 0 to 3 at 90 (±7) days

Proportion of patients with mRS score 0 to 2 at 90 (±7) days

Proportion of patients with mRS score 0 to 1 at 90 (±7) days or return to pre-stroke mRS score (for patients with prestroke mRS > 1)

Midline shift at 48 hours

Proportion of patients with midline shift maximum > 5 mm within 48 hours (%)

Relative hemispheric volume at 48 hours

Net water uptake at 48 hours

Proportion of patients with decompressive craniectomy after EVT

NIHSS score at 5-7 days or at early discharge

EQ-5D-5L VAS at 90 (±7) days

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

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

Proportion of patients with pneumonia

Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT

Incidence of any complications

Incidence of any (serious) adverse events

Other outcomes

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

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

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)

EQ-5D-5L VAS at 1 year

Study contacts

Sponsors and collaborators

Lead sponsor

Registry information

Official study title

Important dates

Related clinical trials

Methylprednisolone Adjunctive to Endovascular Thrombectomy for Stroke