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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,614
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.
Placebo for 3 consecutive days, with a maximum daily dose of 4 vials (Hanhui Pharmaceutical Co., Ltd.)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
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
Time frame: 90±14 days after randomization
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 7±1 days after randomization/discharge or at 36±12 hours after randomization
Rate of hemicraniectomy within 7 days
Rate of hemicraniectomy
Time frame: 7±1 days after randomization/discharge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.