Methylprednisolone With Endovascular Thrombectomy for Large Ischemic Stroke (MATCH)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: Methyprednisolone sodium succinate; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 1614
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xinguang Yang; Phone Number: 86 + 13078895666; Email: yangxinguang0926@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Contact: Xinguang Yang; Phone Number: 86 + 130 7889 5666; Email: yangxinguang0926@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; Methylprednisolone sodium succinate simulant	Drug: Placebo; Placebo for 3 consecutive days, with a maximum daily dose of 4 vials (Hanhui Pharmaceutical Co., Ltd.); Other Names: Methylprednisolone sodium succinate simulant
Experimental: Methylprednisolone group; Methylprednisolone sodium succinate	Drug: Methyprednisolone sodium succinate; 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.; Other Names: Methylprednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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: 4 points total NIHSS at the time of diagnosis compared to immediately before worsening.; 2 point in one NIHSS category. Leading to intubation/hemicraniectomy/ventricular drainage placement or other major medical/surgical intervention. 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

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Principal Investigator: Qingyu Shen, Sun Yat-sen Memorial Hospital，Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: methylprednisolone; endovascular thrombectomy; large infarct core
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemic Stroke; Stroke; Cerebral Infarction; Ischemia; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protective Agents; Neuroprotective Agents; Methylprednisolone Acetate; Prednisolone; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: SYS-5010-202501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD will be available from principal investigator upon reasonable request 6 months after the trial completion.
• IPD Sharing Time Frame: 6 months after the trial completion
• IPD Sharing Access Criteria: The IPD will be available from principal investigator upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No