Large Infarct CorePhase 3MIRACLE-2NCT07202143
Methylprednisolone for Stroke With Large Infarct Core and Post-stroke Lymphocytopenia
A Phase 3 study testing Methylprednisolone sodium succinate and Normal Saline in people with Large Infarct Core and Post-stroke Lymphocytopenia, run by YiLin at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Infarct Core, Post-stroke Lymphocytopenia
- What is being tested?
- Methylprednisolone sodium succinate and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%).
Show all 9Show fewer
- Planned treatment with endovascular thrombectomy (EVT).
- Baseline peripheral blood lymphocyte < 0.8×10#/L
- Informed consent obtained from patients or their legal representatives.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, the First Affiliated Hospital Fujian Medical University
Fuzhou, Fujian, 350005
Yi Lin, MD, 13615039153, linyi7811@163.com
Yi Lin, MD
About this study
Official 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
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.
- Conditions
- Large Infarct Core, Post-stroke Lymphocytopenia
- Being tested
- Methylprednisolone sodium succinate, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone sodium succinateDrug
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 SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone sodium succinate group | Experimental | Not described Receives: Drug: Methylprednisolone sodium succinate |
| Methylprednisolone sodium succinate simulant (normal saline placebo) | Placebo comparator | Not described Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at 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.
Measured: From randomization to 90 (±7) days
Secondary outcomes (19)
Time from randomization to the occurrence of death from any cause at 90 (±7) days
Secondary Efficacy Outcome; To evaluate death rate of the two treatment groups
Measured: From randomization to 90 (±7) days
mRS ordinal shift at 90 (±7) days (scores 5 and 6 are merged)
Secondary Efficacy Outcome
Measured: From randomization to 90 (±7) days
Proportion of patients with mRS score 0 to 4 at 90 (±7) days
Secondary Efficacy Outcome
Measured: From randomization to 90 (±7) days
Proportion of patients with mRS score 0 to 3 at 90 (±7) days
Secondary Efficacy Outcome
Measured: From randomization to 90 (±7) days
Proportion of patients with mRS score 0 to 2 at 90 (±7) days
Secondary Efficacy Outcome
Measured: From randomization to 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)
Secondary Efficacy Outcome
Measured: From randomization to 90 (±7) days
Midline shift at 48 hours
Secondary Efficacy Outcome
Measured: From randomization to 48 hours
Proportion of patients with midline shift maximum > 5 mm within 48 hours (%)
Secondary Efficacy Outcome
Measured: From randomization to 48 hours
Relative hemispheric volume at 48 hours
Secondary Efficacy Outcome
Measured: From randomization to 48 hours
Net water uptake at 48 hours
Secondary Efficacy Outcome
Measured: From randomization to 48 hours
Proportion of patients with decompressive craniectomy after EVT
Secondary Efficacy Outcome
Measured: From randomization until the date of discharge, an average of 1 week
NIHSS score at 5-7 days or at early discharge
Secondary Efficacy Outcome
Measured: From randomization to 5-7 days (or at early discharge)
EQ-5D-5L VAS at 90 (±7) days
Secondary Efficacy Outcome
Measured: From randomization to 90 (±7) days
Proportion of patients with symptomatic intracranial haemorrhage (SICH) within 48 hours after EVT
Primary Safety Outcome. Based on the modified Heidelberg Bleeding Classification.
Measured: From randomization to 48 hours
Proportion of patients with any intracranial haemorrhage (ICH) within 48 hours after EVT
Secondary Safety Outcome. Based on the modified Heidelberg Bleeding Classification.
Measured: From randomization to 48 hours
Proportion of patients with pneumonia
Secondary Safety Outcome
Measured: From randomization until the date of discharge, an average of 1 week
Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT
Secondary Safety Outcome
Measured: From randomization to 7 days
Incidence of any complications
Secondary Safety Outcome
Measured: From date of randomization until the date of discharge, an average of 1 week
Incidence of any (serious) adverse events
Secondary Safety Outcome
Measured: From randomization to 90 (±7) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Sep 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Infarct CoreStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YiLin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YiLin, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202143
- Sponsor's protocol ID
- MRCTA, ECFAH of FMU [2025]887
- Acronym
- MIRACLE-2
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07202143
- Acronym / sponsor ID
- MIRACLE-2 / MRCTA, ECFAH of FMU [2025]887
- Conditions
- Large Infarct Core, Post-stroke Lymphocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- YiLinUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone sodium succinate group | Experimental | Drug: Methylprednisolone sodium succinate |
| Methylprednisolone sodium succinate simulant (normal saline placebo) | Placebo comparator | Drug: Normal Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone sodium succinateMethylprednisolone 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. | Drug | Methylprednisolone sodium succinate group |
| Normal SalineIntravenous 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. | Drug | Methylprednisolone sodium succinate simulant (normal saline placebo) |
Primary outcome
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.
19 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
mRS ordinal shift at 90 (±7) days (scores 5 and 6 are merged)
Time frame: From randomization to 90 (±7) days
Proportion of patients with mRS score 0 to 4 at 90 (±7) days
Time frame: From randomization to 90 (±7) days
Proportion of patients with mRS score 0 to 3 at 90 (±7) days
Time frame: From randomization to 90 (±7) days
Proportion of patients with mRS score 0 to 2 at 90 (±7) days
Time frame: From randomization to 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)
Time frame: From randomization to 90 (±7) days
Midline shift at 48 hours
Time frame: From randomization to 48 hours
Proportion of patients with midline shift maximum > 5 mm within 48 hours (%)
Time frame: From randomization to 48 hours
Relative hemispheric volume at 48 hours
Time frame: From randomization to 48 hours
Net water uptake at 48 hours
Time frame: From randomization to 48 hours
Proportion of patients with decompressive craniectomy after EVT
Time frame: From randomization until the date of discharge, an average of 1 week
NIHSS score at 5-7 days or at early discharge
Time frame: From randomization to 5-7 days (or at early discharge)
EQ-5D-5L VAS at 90 (±7) days
Time frame: From randomization to 90 (±7) days
Proportion of patients with symptomatic intracranial haemorrhage (SICH) within 48 hours after EVT
Time frame: From randomization to 48 hours
Proportion of patients with any intracranial haemorrhage (ICH) within 48 hours after EVT
Time frame: From randomization to 48 hours
Proportion of patients with pneumonia
Time frame: From randomization until the date of discharge, an average of 1 week
Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT
Time frame: From randomization to 7 days
Incidence of any complications
Time frame: From date of randomization until the date of discharge, an average of 1 week
Incidence of any (serious) adverse events
Time frame: From randomization to 90 (±7) days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Large Infarct Core
Recruiting
EVT in Acute Basilar Artery Occlusion With Large Infarction Core
Basilar Artery Occlusion, Large Ischemic Core
RecruitingObservational study
Basilar Artery Occlusion Chinese Endovascular Registry in Patients With Large-Core Infarct
Basilar Artery Occlusion, Ischemic Stroke
Active, not recruitingPhase 3
Methylprednisolone Adjunctive to Endovascular Thrombectomy for Stroke
Acute Ischemic Stroke, Large Infarct Core
Not yet recruiting
Basilar Artery Occlusion Chinese Endovascular Trial in Patients With Large Core Infarct
Basilar Artery Occlusion, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolone sodium succinate and Normal Saline in people with Large Infarct Core and Post-stroke Lymphocytopenia, run by YiLin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Lin, MD (86-13615039153, linyi7811@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality at 90 (±7) days (time frame: From randomization to 90 (±7) days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025; AzTrials last refreshed its copy on 1 Nov 2026.