Acute Ischemic StrokePhase 3MATCHNCT06870448
Methylprednisolone With Endovascular Thrombectomy for Large Ischemic Stroke
A Phase 3 study testing Methyprednisolone sodium succinate in people with Acute Ischemic Stroke, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
It is uncertain whether intravenous methylprednisolone improves outcomes for acute anterior circulation large vascular occlusion (LVO) patients with a large infarct core. In this study, the investigators assume that methylprednisolone plus endovascular thrombectomy (EVT) might be superior to EVT alone for patients who… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Methyprednisolone sodium succinate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,614 participants
- Where
- 1 siteChina
- Study dates
- Apr 2025to Apr 2029
- 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
- 1. Age ≥18 years;
- 2. Clinically diagnosed with acute ischemic stroke and NIHSS ≥6;
- 3. CT angiography (CTA), MR angiography (MRA) or digital subtraction angiography (DSA) confirmed occlusion of intracranial internal carotid artery (ICA) or M1/M2 segments of middle cerebral artery (MCA) and plan to undergo EVT;
- 4. ASPECTS ≤5 (based on NCCT) or infarct core volume ≥70mL (defined as rCBF <30% on CT perfusion or ADC <620 on MRI);
- 5. Time from symptom onset to randomization within 24 hours (from last known well);
- 6. Pre-stroke mRS score 0-2;
- 7. Written informed consent signed by patients or their family members.
Who cannot join
- 1. Intracranial hemorrhage confirmed by CT or MRI;
- 2. Allergic to glucocorticoids or placebo components;
- 3. Allergic to contrast agent;
- 4. Presence of severe infectious disease unsuitable for glucocorticoid therapy or any other contraindication to glucocorticoid use;
- 5. Known genetic or acquired coagulopathy, coagulation factor deficiency, use of warfarin with an international normalized ratio (INR) >1.7, or use of novel oral anticoagulants within 48 hours of symptom onset;
- 6. Platelet count <90×10^9/L;
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- 7. Random blood glucose <2.8 mmol/L or >22.2 mmol/L;
- 8. History of gastrointestinal or urinary tract bleeding within the last month;
- 9. Current participation in another interventional clinical study;
- 10. Pregnant or lactating women;
- 11. Renal dysfunction (glomerular filtration rate <30 ml/min or serum creatinine >220 μmol/L [2.5 mg/dl]);
- 12. Uncontrolled hypertension with persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, refractory to medical management;
- 13. Life expectancy less than 6 months due to malignancy or severe cardiopulmonary disease;
- 14. Other conditions deemed unsuitable for the study by the investigator, such as inability to comprehend or comply with study procedures or follow-up due to mental illness, cognitive or emotional disorder.
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
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Xinguang Yang, 86 + 130 7889 5666, yangxinguang0926@163.com
About this study
Official title: Methylprednisolone With Endovascular Thrombectomy for Large Ischemic Stroke (MATCH): A Randomized Controlled Trial
It is uncertain whether intravenous methylprednisolone improves outcomes for acute anterior circulation large vascular occlusion (LVO) patients with a large infarct core. In this study, the investigators assume that methylprednisolone plus endovascular thrombectomy (EVT) might be superior to EVT alone for patients who have evidence of a large infarct volume. The objective of the study was to establish the efficacy and safety of methylprednisolone with EVT in patients presenting with symptoms of acute ischemic stroke from LVO in the anterior circulation and having a large infarct volume.
Read the detailed description
MATCH is a multicentered, prospective, randomized, controlled trial. A total of 1614 patients (age ≥18 years) with NIHSS ≥6 and pre-stroke modified Rankin Scale (mRS) 0-2, within 24 hours of symptom onset of acute ischemic stroke, who has the imaging evidence of an occlusion of the intracranial internal carotid artery (ICA) and/or M1/M2 segment of middle cerebral artery (MCA), large infarct core [defined as: 1) NCCT (non-contrast computed tomography) ASPECTS (Alberta Stroke Program Early CT Score) 0-5, decided on last head CT scan before randomization. Or 2) Ischemic core volume ≥70ml, determined either on a diffusion-weighted MRI map based on an ADC (Apparent Diffusion Coefficient) threshold of less than 620 or on CTP (computed tomography perfusion) image with rCBF<30%] will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content. One group will receive methylprednisolone plus EVT, the other group will receive methylprednisolone simulant plus EVT. The primary objective is to evaluate the efficacy of methylprednisolone with EVT in patients presenting with symptoms of acute ischemic stroke from LVO in the anterior circulation and having a large infarct volume. The study consists of four visits including the day of randomization, 36 hours after randomization, 7 days or discharge, and 90 days. The primary outcome is a shift in the distribution of scores on the mRS at 90 days. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Sun Yat-Sen Memorial Hospital.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Methyprednisolone sodium succinate, Placebo
- Keywords
- large infarct core, methylprednisolone, endovascular thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyprednisolone sodium succinateDrug
Also called Methylprednisolone
Methylprednisolone at a dose of 2 mg/kg/day for 3 consecutive days, with a maximum daily dose of 160 mg (4 vials, 40 mg per vial, Hanhui Pharmaceutical Co., Ltd.). The initial study drug will be administered as soon as possible after randomization. It is recommended that the initial study drug be administered before arterial access closure.
PlaceboDrug
Also called Methylprednisolone sodium succinate simulant
Placebo for 3 consecutive days, with a maximum daily dose of 4 vials (Hanhui Pharmaceutical Co., Ltd.)
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone group | Experimental | Methylprednisolone sodium succinate Receives: Drug: Methyprednisolone sodium succinate |
| Placebo group | Placebo comparator | Methylprednisolone sodium succinate simulant Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day distribution of patients across the ordinal modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms. Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead
Measured: 90±14 days after randomization
Secondary outcomes (8)
modified Rankin Scale (mRS) 0-1 at 90±14 days
Excellent functional outcome defined as a modified Rankin Scale (mRS) score of 0-1 at 90±14 days
Measured: 90±14 days after randomization
modified Rankin Scale (mRS) 0-2 at 90±14 days
Good clinical outcome defined as a modified Rankin Scale (mRS) score of 0-2 at 90±14 days
Measured: 90±14 days after randomization
modified Rankin Scale (mRS) 0-3 at 90±14 days
Independent ambulation defined as a modified Rankin Scale (mRS) score of 0-3 at 90±14 days
Measured: 90±14 days after randomization
modified Rankin Scale (mRS) 0-4 at 90±14 days
No constant care required defined as modified Rankin Scale (mRS) 0-4 at 90±14 days
Measured: 90±14 days after randomization
Quality of Life (EuroQoL 5-Dimension 5-Level) at 90±14 days
The value of Quality of Life (EuroQoL 5-Dimension 5-Level) at 90±14 days
Measured: 90±14 days after randomization
National Institutes of Health Stroke Scale (NIHSS) score change from baseline
National Institutes of Health Stroke Scale (NIHSS) score change from baseline, at 7 (±1) days or at discharge
Measured: 7±1 days after randomization/discharge
Infarct core volume change from baseline
Infarct core volume change from baseline, assessed with NCCT at 7±1 days after randomization/at discharge or with MRI at 36±12 hours
Measured: 7±1 days after randomization/discharge or at 36±12 hours after randomization
Rate of hemicraniectomy within 7 days
Rate of hemicraniectomy
Measured: 7±1 days after randomization/discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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
- 1,614 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qingyu Shen, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870448
- Sponsor's protocol ID
- SYS-5010-202501
- Acronym
- MATCH
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be available from principal investigator upon reasonable request 6 months after the trial completion.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylprednisolone With Endovascular Thrombectomy for Large Ischemic Stroke (MATCH): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06870448
- Acronym / sponsor ID
- MATCH / SYS-5010-202501
- Conditions
- Acute Ischemic Stroke
- Keywords
- large infarct core, methylprednisolone, endovascular thrombectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,614 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 11 Mar 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.
It is uncertain whether intravenous methylprednisolone improves outcomes for acute anterior circulation large vascular occlusion (LVO) patients with a large infarct core. In this study, the investigators assume that methylprednisolone plus endovascular thrombectomy (EVT) might be superior to EVT alone for patients who have evidence of a large infarct volume. The objective of the study was to establish the efficacy and safety of methylprednisolone with EVT in patients presenting with symptoms of acute ischemic stroke from LVO in the anterior circulation and having a large infarct volume.
Detailed description
MATCH is a multicentered, prospective, randomized, controlled trial. A total of 1614 patients (age ≥18 years) with NIHSS ≥6 and pre-stroke modified Rankin Scale (mRS) 0-2, within 24 hours of symptom onset of acute ischemic stroke, who has the imaging evidence of an occlusion of the intracranial internal carotid artery (ICA) and/or M1/M2 segment of middle cerebral artery (MCA), large infarct core [defined as: 1) NCCT (non-contrast computed tomography) ASPECTS (Alberta Stroke Program Early CT Score) 0-5, decided on last head CT scan before randomization. Or 2) Ischemic core volume ≥70ml, determined either on a diffusion-weighted MRI map based on an ADC (Apparent Diffusion Coefficient) threshold of less than 620 or on CTP (computed tomography perfusion) image with rCBF<30%] will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content. One group will receive methylprednisolone plus EVT, the other group will receive methylprednisolone simulant plus EVT. The primary objective is to evaluate the efficacy of methylprednisolone with EVT in patients presenting with symptoms of acute ischemic stroke from LVO in the anterior circulation and having a large infarct volume. The study consists of four visits including the day of randomization, 36 hours after randomization, 7 days or discharge, and 90 days. The primary outcome is a shift in the distribution of scores on the mRS at 90 days. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Sun Yat-Sen Memorial Hospital.
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 group | Experimental | Drug: Methyprednisolone sodium succinateMethylprednisolone sodium succinate |
| Placebo group | Placebo comparator | Drug: PlaceboMethylprednisolone sodium succinate simulant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Age ≥18 years;
- 2. Clinically diagnosed with acute ischemic stroke and NIHSS ≥6;
- 3. CT angiography (CTA), MR angiography (MRA) or digital subtraction angiography (DSA) confirmed occlusion of intracranial internal carotid artery (ICA) or M1/M2 segments of middle cerebral artery (MCA) and plan to undergo EVT;
- 4. ASPECTS ≤5 (based on NCCT) or infarct core volume ≥70mL (defined as rCBF <30% on CT perfusion or ADC <620 on MRI);
- 5. Time from symptom onset to randomization within 24 hours (from last known well);
Key exclusion criteria (14 listed)
- 1. Intracranial hemorrhage confirmed by CT or MRI;
- 2. Allergic to glucocorticoids or placebo components;
- 3. Allergic to contrast agent;
- 4. Presence of severe infectious disease unsuitable for glucocorticoid therapy or any other contraindication to glucocorticoid use;
- 5. Known genetic or acquired coagulopathy, coagulation factor deficiency, use of warfarin with an international normalized ratio (INR) >1.7, or use of novel oral anticoagulants within 48 hours of symptom onset;
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 |
|---|---|---|
| Methyprednisolone sodium succinateAlso: MethylprednisoloneMethylprednisolone at a dose of 2 mg/kg/day for 3 consecutive days, with a maximum daily dose of 160 mg (4 vials, 40 mg per vial, Hanhui Pharmaceutical Co., Ltd.). The initial study drug will be administered as soon as possible after randomization. It is recommended that the initial study drug be administered before arterial access closure. | Drug | Methylprednisolone group |
| PlaceboAlso: Methylprednisolone sodium succinate simulantPlacebo for 3 consecutive days, with a maximum daily dose of 4 vials (Hanhui Pharmaceutical Co., Ltd.) | Drug | Placebo group |
Primary outcome
90-day distribution of patients across the ordinal modified Rankin Scale (mRS)
Time frame: 90±14 days after randomization
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. Score 0: No symptoms. Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms. Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Score 6: Dead
8 secondary outcomes
modified Rankin Scale (mRS) 0-1 at 90±14 days
Time frame: 90±14 days after randomization
modified Rankin Scale (mRS) 0-2 at 90±14 days
Time frame: 90±14 days after randomization
modified Rankin Scale (mRS) 0-3 at 90±14 days
Time frame: 90±14 days after randomization
modified Rankin Scale (mRS) 0-4 at 90±14 days
Time frame: 90±14 days after randomization
Quality of Life (EuroQoL 5-Dimension 5-Level) at 90±14 days
Time frame: 90±14 days after randomization
National Institutes of Health Stroke Scale (NIHSS) score change from baseline
Time frame: 7±1 days after randomization/discharge
Infarct core volume change from baseline
Time frame: 7±1 days after randomization/discharge or at 36±12 hours after randomization
Rate of hemicraniectomy within 7 days
Time frame: 7±1 days after randomization/discharge
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 11 Mar 2025.
- Individual participant dataSharing planned: Yes. The IPD will be available from principal investigator upon reasonable request 6 months after the trial completion.
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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.
Qingyu Shen principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 Methyprednisolone sodium succinate in people with Acute Ischemic Stroke, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 7 inclusion and 14 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: opening soon, as of the sponsor's last update on 11 Mar 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 Xinguang Yang (86 + 13078895666, yangxinguang0926@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day distribution of patients across the ordinal modified Rankin Scale (mRS) (time frame: 90±14 days after randomization). 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 11 Mar 2025.