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Methylprednisolone as Adjunct to Endovascular Thrombectomy for Large Vessel Occlusion Stroke ? A multicenter, randomized, double-blind, placebo-controlled clinical trial

Methylprednisolone as Adjunct to Endovascular Thrombectomy for Large Vessel Occlusion Stroke ? A multicenter, randomized, double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098085
Enrollment
Unknown
Registered
2025-03-03
Start date
2025-03-08
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Ischemic Stroke

Interventions

Sponsors

Second Affiliated Hospital of Army Medical University, PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age >=18 years; 2) Within 24 hours of stroke onset; 3) Anterior circulation intracranial large vessel occlusive stroke confirmed by CTA/MRA/DSA; 4) NIHSS score >5 points; 5) The admission blood routine test revealed white blood cells >10×10^9/L and lymphocytes <0.8×10^9/L. 6) Received endovascular therapy; 7) Patients or their family members provided written informed consent.

Exclusion criteria

Exclusion criteria: 1) Suspected or confirmed intracranial hemorrhage by head CT or MRI; 2) Pre-stroke mRS score >= 2; 3) Pregnant or lactating women; 4) Allergy to contrast agent; 5) Allergy to glucocorticoid; 6) Currently participating in other clinical trial; 7) Systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg after aggressive treatment; 8) Genetic or acquired bleeding tendency, deficiency of coagulation factors; or use of anticoagulants with INR>1.7; 9) Serum glucose lower than 2.8mmol/L (50mg/dl) or greater than 22.2mmol/L (400mg/dl); 10) Arterial tortuosity preventing thrombectomy device access to target vessel; 11) Serious systemic hemorrhage in the past 30 days; 12) Chronic hemodialysis and severe renal insufficiency patients (glomerular filtration rate220µmol/L; 13) Any disease that leads to an expected lifespan of less than 6 months; 14) Unable to complete follow-up as expected; 15) Previous intracranial aneurysm, arteriovenous malformation; 16) Previous mass lesions; 17) Macular edema; 18) History of Mohs type II second/third degree atrioventricular block or sick sinus syndrome; 19)Systemic infectious diseases.

Design outcomes

Primary

MeasureTime frame
Changes of 90-day mRS Score;

Secondary

MeasureTime frame
The proportion of 90-day mRS Scores 0-1;The proportion of 90-day mRS Scores 0-2;The proportion of 90-day mRS Scores 0-3;The proportion of 90-day mRS Scores 0-4;Changes of NIHSS score 5-7 days after surgery;90-day EQ-5D scale score;90-day mortality;Incidence of symptomatic intracranial hemorrhage;Incidence of any intracranial hemorrhage within 48 hours;Incidence of malignant cerebral edema within 48h after surgery;

Countries

China

Contacts

Public ContactQingwu Yang

Second Affiliated Hospital of Army Medical University, PLA

yangqwmlys@163.com+86 136 5763 8868

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026