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Methylprednisolone for acute large vessel occlusion: a randomized double-blind, placebo-controlled trial in revascularization patients

Methylprednisolone for acute large vessel occlusion: a multicenter, randomized double-blind, placebo-controlled trial in revascularization patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051729
Enrollment
Unknown
Registered
2021-10-01
Start date
2022-02-09
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Interventions

Placebo group:Standard pharmaceutical therapy
Methylprednisolone group:Standard pharmaceutical therapy and methylprednisolone

Sponsors

The Second Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. Presenting with AIS with symptoms within 24 hours from time last known well 3. Baseline National Institutes of Health Stroke Scale (NIHSS) >5 4. Anterior circulation ischemic stroke was determined according to clinical symptoms and imaging examination 5. Baseline Alberta Stroke Program Early CT Score (ASPECTS) ? 3 6. Occlusion of the intracranial internal carotid artery, the M1- or M2-segment of the middle cerebral artery confirmed by CTA, MR angiography, or digital subtraction angiography and planned treatment with EVT 7. Informed consent obtained from patients or their legal representatives.

Exclusion criteria

Exclusion criteria: 1. Intracranial hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI); 2. mRS score >= 2 before onset; 3. Pregnant or lactating women; 4. Allergic to contrast agents; 5. Allergic to glucocorticoids; 6. Participating in other clinical trials; 7. Systolic blood pressure > 185 mmHg or diastolic pressure > 110 mmHg, and oral antihypertensive drugs can not control; 8. Genetic or acquired bleeding constitution, lack of anticoagulant factors; Or oral anticoagulants and INR > 1.7; 9. Blood sugar 22.2 mmol/L (400 mg/dl), platelet 220 umol/L [2.5 mg/ dL]); 13. Life expectancy due to any advanced disease < 6 months; 14. Follow-up is not expected to be completed; 15. Intracranial aneurysm and arteriovenous malformation; 16. Brain tumors with imaging mass effect; 17. Systemic infectious diseases.

Design outcomes

Primary

MeasureTime frame
MRS (Modified Rankin Scale) score at 90 days;Death;mRS score;

Secondary

MeasureTime frame
Improvement of MRS scores;Incidence of complications of intracranial hemorrhage;EQ-5D scale score (EuroQol five dimensions questionnaire);Dichotomized mRS score;Gastrointestinal bleeding 7 days after surgery;Pulmonary infection during hospitalization;Ordinal mRS score;

Countries

China

Contacts

Public ContactZi Wenjie, Yang Qingwu

The Second Affiliated Hospital of the Army Medical University

yangqwmlys@163.comn+86 136 5763 8868

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 2, 2026