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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone group | Experimental | Methylprednisolone sodium succinate |
|
| Placebo group | Placebo Comparator | Methylprednisolone sodium succinate simulant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methyprednisolone sodium succinate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90±14 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90±14 days after randomization |
| modified Rankin Scale (mRS) 0-2 at 90±14 days |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality within 90 days (Safety Outcome) | All-cause mortality within 90 days | 90±14 days after randomization |
| Time to all-cause mortality within 90 days (Safety Outcome) | Time to all-cause death is defined as the time from randomization to the time of death |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinguang Yang | Contact | 86 + 13078895666 | yangxinguang0926@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qingyu Shen | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510120 | China |
The IPD will be available from principal investigator upon reasonable request 6 months after the trial completion.
6 months after the trial completion
The IPD will be available from principal investigator upon reasonable request.
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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|
|
| Placebo | Drug | Placebo for 3 consecutive days, with a maximum daily dose of 4 vials (Hanhui Pharmaceutical Co., Ltd.) |
|
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Good clinical outcome defined as a modified Rankin Scale (mRS) score of 0-2 at 90±14 days
| 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 | 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 | 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 | 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 | 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 | 7±1 days after randomization/discharge or at 36±12 hours after randomization |
| Rate of hemicraniectomy within 7 days | Rate of hemicraniectomy | 7±1 days after randomization/discharge |
| Randomization up to 90±14 days after randomization |
| Rate of symptomatic intracranial hemorrhage (sICH) per Heidelberg Bleeding Classification within 48 hours (Safety Outcome) | Heidelberg Bleeding Classification was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item below:
Absence of alternative explanation for deterioration. | 36±12 hours after randomization |
| Any serious adverse events and steroid-related adverse events (hyperglycemia, infection, gastrointestinal hemorrhage) within 90 days (Safety Outcome) | Safety will be assessed according to common terminology criteria for adverse events version 5.0 (CTCAE 5.0) | From the signing of informed consent up to 90±14 days after randomization |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |