Status:
NOT_YET_RECRUITING
Methylprednisolone Sodium Succinate With Endovascular ThRombectomy for Large Ischemic STroke
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Ischemic Stroke, Acute
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
It is uncertain whether intravenous methylprednisolone improves outcomes for acute anterior circulation large vessel occlusion (LVO) patients with a large infarct core. In this study, the investigator...
Detailed Description
The PEARL-MERIT is a multicenter, prospective, randomized, double-blind, placebo-controlled trial. A total of 912 patients (aged 18-85 years) within 24 hours of symptom onset of acute ischemic stroke,...
Eligibility Criteria
Inclusion
- Aged 18 to 85 years;
- Clinically diagnosed acute ischemic stroke with screening NIHSS ≥6;
- Time from last known well to randomization ≤24 hours;
- Pre-stroke mRS score of 0-1;
- Occlusion of the responsible vessel confirmed by CT angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA) in intracranial segment of internal carotid artery (ICA), M1 or M2 segment of middle cerebral artery (MCA), and plan to undergo EVT;
- Alberta Stroke Program Early CT Score (ASPECTS) of 0-5 on NCCT, or ischemic core volume ≥70 mL (defined as regional cerebral blood flow \[rCBF\] \<30% on CT perfusion \[CTP\] or apparent diffusion coefficient \[ADC\] \<620×10-⁶ mm²/s on MRI);
- Informed consent obtained.
Exclusion
- Intracranial hemorrhage on NCCT or MRI;
- Allergy to corticosteroids;
- Allergy to contrast agents;
- Severe infectious disease unsuitable for corticosteroid therapy or concurrent contraindications to corticosteroid treatment;
- Random blood glucose \>22.2 mmol/L (400 mg/dL);
- Known hereditary or acquired bleeding diathesis, coagulation factor deficiency, use of warfarin with an international normalized ratio (INR) \>1.7, or administration of novel oral anticoagulants within 48 hours of symptom onset;
- Platelet count \<90×10⁹/L;
- History of gastrointestinal or urinary tract bleeding within the last month;
- Current participation in another interventional clinical trial;
- Pregnancy or lactating;
- Renal dysfunction with an estimated glomerular filtration rate (eGFR) \<30 mL/min or serum creatinine \>220 μmol/L (2.5 mg/dL);
- Persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg despite antihypertensive treatment;
- Life expectancy \<6 months due to terminal illnesses such as malignancy or severe cardiopulmonary disease;
- Intracranial aneurysm or arteriovenous malformation;
- Intracranial tumour with mass effect on imaging (except for small meningiomas);
- Other conditions deemed unsuitable for study participation by the investigator, including inability to comprehend and/or comply with study procedures and/or follow-up due to psychiatric, cognitive, or emotional disorders.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
912 Patients enrolled
Trial Details
Trial ID
NCT07175649
Start Date
October 1 2025
End Date
December 1 2029
Last Update
September 16 2025
Active Locations (1)
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1
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120