AzTrials
AzTrials

Acute Ischemic StrokePhase 3MIRACLENCT06360458

Methylprednisolone Adjunctive to Endovascular Thrombectomy for Stroke

A Phase 3 study testing Methylprednisolone sodium succinate in people with Acute Ischemic Stroke and Large Infarct Core, run by Wan-Jin Chen at 99 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke, Large Infarct Core
What is being tested?
Methylprednisolone sodium succinate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
928 participants
Where
99 sitesChina
Study dates
1 Aug 2024to 30 Jun 2030
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 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.

Who cannot join

  • 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.
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

99 sites in 1 country.

99 sites in 1 country

China99 sites

  • Anxi County Hospital

    Anxi, Fujian, 362400

  • Anxi Hospital of Traditional Chinese Medicine

    Anxi, Fujian, 362400

  • Baotou Central Hospital

    Baotou, Inner Mongolia, 14040

  • Biyan People's Hospital

    Biyang, Henan, 463700

  • Bozhou People's Hospital

    Bole, Xinjiang, 833400

  • Chongzhou People's Hospital

    Chengdu, Sichuan, 611230

  • The Central Hospital of Enshi Tujia And Miao Automomous Prefecture

    Enshi, Hubei, 445000

  • Ezhou Central Hospital

    Ezhou, Hubei, 436000

  • Fuqing City Hospital of Fujian

    Fuqing, Fujian, 350300

  • Fuzhou University Affiliated Provincial Hospital

    Fuzhou, Fujian, 350001

  • Union Hospital Affiliated to Fujian Medical University

    Fuzhou, Fujian, 350001

  • The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine

    Fuzhou, Fujian, 350003

  • Department of Neurology, First Affiliated Hospital Fujian Medical University

    Fuzhou, Fujian, 350005

  • 900th Hospital of PLA Joint Logistic Support Force

    Fuzhou, Fujian, 350025

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341000

  • Ganzhou People's Hospital, Ganzhou (G.Z.)

    Ganzhou, Jiangxi, 341000

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

  • Guangzhou First People's Hospital

    Guangzhou, Guangzhou, 510180

  • Gulin County People's Hospital

    Gulin, Sichuan, 646500

  • The First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 570102

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 570311

  • The First Affiliated Hospital of USTC

    Hefei, Anhui, 230001

  • Hefei First People's Hospital

    Hefei, Anhui, 230061

  • Qichun People's Hospital

    Huanggang, Hubei, 435300

  • Huanggang Central Hospital

    Huanggang, Hubei, 438000

  • Huangshi Central Hospital

    Huangshi, Hubei, 435000

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    Jinan, Shandong, 250011

  • Jinan Central Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250013

  • Jingdezhen First People's Hospital

    Jingdezhen, Jiangxi, 333000

  • Yangtze University Affiliated Hospital

    Jingzhou, Hubei, 434000

  • Jingzhou Hospital Affiliated to Yangtze University

    Jingzhou, Hubei, 434020

  • Jiujiang University Affiliated Hospital

    Jiujiang, Jiangxi, 332000

  • The First People's Hospital of Jiujiang

    Jiujiang, Jiangxi, 332000

  • Gansu Province Central Hospital

    Lanzhou, Gansu, 730050

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

  • Liaocheng third people's hospital

    Liaocheng, Shandong, 252000

  • Lichuan City Ethnic Traditional Chinese Medical Hospital

    Lichuan, Hubei, 445400

  • Longyan First Affiliated Hospital of Fujian Medical University

    Longyan, Fujian, 364000

  • Maoming Hospital of Traditional Chinese Medicine

    Maoming, Guangdong, 525000

  • Maoming people's hospital

    Maoming, Guangdong, 525000

  • Mianyang 404 Hospital

    Mianyang, Sichuan, 621000

  • Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China

    Mianyang, Sichuan, 621000

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • The First Affiliated Hospital, Jiangxi Medical College, Nanchang University

    Nanchang, Jiangxi, 330006

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637000

  • Nanping First Hospital

    Nanping, Fujian, 353000

  • Mindong Hospital

    Ningde, Fujian, 352100

  • Ningde Municipal Hospital, Ningde Normal University

    Ningde, Fujian, 352100

  • Putian University Affiliated Hospital

    Putian, Fujian, 351100

  • The First Hospital of Putian City

    Putian, Fujian, 351100

  • The Affiliated Hospital of Qingdao Univercity

    Qingdao, Shandong, 266003

  • The First People's Hospital of Qingzhen

    Qingzhen, Guizhou, 551400

  • Quanzhou First Hospital Affiliated to Fujian Medical University

    Quanzhou, Fujian, 362000

  • The 910th Hospital of the Joint Logistics Support Force of the Chinese PLA

    Quanzhou, Fujian, 362000

  • The Second Affiliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000

  • Qujing NO.1 Hospital

    Qujing, Yunnan, 655000

  • Sanming First Hospital

    Sanming, Fujian, 365000

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Shantou Central Hospital

    Shantou, Guangdong, 515031

  • Shaowu Municiple Hospital

    Shaowu, Fujian, 354000

  • Shiyan Hospital of Integrated Traditional and Western Medicine

    Shiyan, Hubei, 442000

  • Shiyan Renmin Hospital

    Shiyan, Hubei, 442000

  • Taihe Hospital Affiliated to Hubei University of Medicine

    Shiyan, Hubei, 442000

  • Suining Central Hospital

    Suining, Sichuan, 629000

  • The Second Affiliated Hospital of Shandong First Medical University

    Tai’an, Shandong, 271000

  • Taihe County People's Hospital

    Taihe Chengguanzhen, Anhui, 236600

  • Cardiovascular Hospital Affiliated to Shanxi Medical University

    Taiyuan, Shanxi, 30001

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 30012

  • Tianjin Huanhu Hospital

    Tianjin, Tian, 300350

  • The First People's Hospital of Tianmen in Hubei Province

    Tianmen, Hubei, 431700

  • Xihua People's Hospital

    Wacheng Neighborhood, Henan, 466600

  • Wuhan Hankou Hospital

    Wuhan, Hubei, 430012

  • The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430014

  • Wuhan NO.1 Hospital

    Wuhan, Hubei, 430022

  • Tongji hospital, Tongji medical college, Huazhong university of science and technology

    Wuhan, Hubei, 430030

  • The Third People's Hospital of Hubei Province

    Wuhan, Hubei, 430033

  • Wuhan University Renmin Hospital

    Wuhan, Hubei, 430060

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

  • The First people's Hospital of Jiangxia District

    Wuhan, Hubei, 430200

  • Yijishan Hospital of Wannan Medical College

    Wuhu, Anhui, 241001

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Zhongshan Hosipital Xiamen University

    Xiamen, Fujian, 361004

  • Xiangyang Hospital of Traditional Chinese Medicine

    Xiangyang, Hubei, 441000

  • Xiangyang No.1 People's Hospital, Hubei University of Medicine.

    Xiangyang, Hubei, 441000

  • Xianning Central Hospital

    Xianning, Hubei, 437100

  • The First People's Hospital of Xianyang

    Xianyang, Shaanxi, 712000

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221002

  • The Second People's Hospital of Yichang

    Yichang, Hubei, 443000

  • Yingtan people's hospital

    Yingtan, Jiangxi, 335000

  • Red Cross Hospital of Yulin City

    Yulin, Guangxi, 537000

  • 909th Hospital of PLA Joint Logistic Support Force

    Zhangzhou, Fujian, 363000

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, Fujian, 363000

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524001

  • Central people' s hospital of zhanjiang

    Zhanjiang, Guangdong, 524037

  • Zhoukou Centeral Hospital

    Zhoukou, Henan, 466000

  • ZhuMaDian Centeral Hospital

    Zhumadian, Henan, 463000

  • Zhumadian First People's Hospital

    Zhumadian, Henan, 463000

  • Zigong Third People's Hospital

    Zigong, Sichuan, 643020

  • Zoucheng People's Hospital, Shandong Province

    Zoucheng, Shandong, 273500

Other trials in China

About this study

Official 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)

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.

Being tested
Methylprednisolone sodium succinate, Placebo
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methylprednisolone sodium succinateDrug

    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.

  • PlaceboDrug

    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.

Study groups in NCT06360458
Study groupRoleWhat they receive
Methylprednisolone sodium succinate groupExperimentalNot described
Placebo groupPlacebo comparatorMethylprednisolone sodium succinate simulant
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality at 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.

    Measured: From randomization to 90 (±14) days

Secondary outcomes (19)

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

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

    Measured: From randomization to 90 (±14) days

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

    Secondary Efficacy Outcome

    Measured: From randomization to 90 (±14) days

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

    Secondary Efficacy Outcome

    Measured: From randomization to 90 (±14) days

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

    Secondary Efficacy Outcome

    Measured: From randomization to 90 (±14) days

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

    Secondary Efficacy Outcome

    Measured: From randomization to 90 (±14) days

  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)

    Secondary Efficacy Outcome

    Measured: From randomization to 90 (±14) days

  7. Midline shift at 48 hours

    Secondary Efficacy Outcome

    Measured: From randomization to 48 hours

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

    Secondary Efficacy Outcome

    Measured: From randomization to 48 hours

  9. Relative hemispheric volume at 48 hours

    Secondary Efficacy Outcome.

    Measured: From randomization to 48 hours

  10. Net water uptake at 48 hours

    Secondary Efficacy Outcome

    Measured: From randomization to 48 hours

  11. Proportion of patients with decompressive craniectomy after EVT

    Secondary Efficacy Outcome

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

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

    Secondary Efficacy Outcome

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

  13. EQ-5D-5L VAS at 90 (±14) days

    Secondary Efficacy Outcome

    Measured: From randomization to 90 (±14) days

  14. 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

  15. 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

  16. Proportion of patients with pneumonia

    Secondary Safety Outcome

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

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

    Secondary Safety Outcome

    Measured: From randomization to 7 days

  18. Incidence of any complications

    Secondary Safety Outcome

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

  19. Incidence of any (serious) adverse events

    Secondary Safety Outcome

    Measured: From randomization to 90 (±14) days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2024
  2. Study start1 Aug 2024
  3. Primary completion30 Sep 2025
  4. Study completion30 Jun 2030 (estimated)

Resources

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
928 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06360458
Sponsor's protocol ID
MRCTA,ECFAH of FMU[2024]368-1
Acronym
MIRACLE
Status last verified
Nov 2025
First submitted
7 Apr 2024
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methylprednisolone sodium succinate in people with Acute Ischemic Stroke and Large Infarct Core, run by Wan-Jin Chen at 99 sites 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 8 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality at 90 (±14) days (time frame: From randomization to 90 (±14) days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06360458.

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 3 Dec 2025.

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