Methylprednisolone Adjunctive to Endovascular Treatment for Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

Methylprednisolone in Adjunctive to Endovascular Treatment for Patients With Acute Ischemic Strokes With Established Large Infarct: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06360458
• Other study ID #: MRCTA,ECFAH of FMU[2024]368
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 1, 2024
• Est. completion date: March 1, 2028

Study information

• Verified date: April 2024
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Wan-Jin Chen, MD
• Phone: 86-13860601359
• Email: wanjinchen75[@]fjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The efficacy and safety of methylprednisolone in acute ischemic stroke patients with large infarct cores (ASPECTS score < 6) due to anterior circulation large vessel occlusion have not been clearly established. This is a multi-center, randomized, double-blind, placebo-controlled trial to investigate early combination therapy with methylprednisolone for reperfusion in acute large core infarction.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 735
• Est. completion date: March 1, 2028
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.

• Presenting with AIS with symptoms within 12 hours from time last known well.

• Anterior circulation ischemic stroke was determined according to clinical symptoms and imaging examination.

• Occlusion of the intracranial internal carotid artery, the M1- or M2-segment of the middle cerebral artery confirmed by CT angiography, MR angiography, or digital subtraction angiography.

• Baseline National Institutes of Health Stroke Scale (NIHSS)=6.

• Baseline Alberta Stroke Program Early CT Score (ASPECTS)<6.

• Planned treatment with endovascular therapy (EVT).

• Informed consent obtained from patients or their legal representatives.

Exclusion Criteria:

• Intracranial hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI).

• mRS score >= 2 before onset.

• Pregnant or lactating women.

• Allergic to contrast agents or glucocorticoids.

• Participating in other clinical trials.

• Systolic blood pressure >185 mmHg or diastolic pressure >110 mmHg, and oral antihypertensive drugs can not control.

• Genetic or acquired bleeding constitution, lack of anticoagulant factors, or oral anticoagulants and INR > 1.7.

• Blood sugar < 2.8 mmol/L (50 mg/dl) or > 22.2 mmol/L (400 mg/dl), platelet < 90 x 10^9/L.

• The artery is tortuous so that the thrombectomy device cannot reach the target vessel.

• Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate < 30 ml/min or serum creatinine > 220 umol/L [2.5 mg/ dL]).

• Life expectancy due to any advanced disease < 6 months.

• Follow-up is not expected to be completed.

• Intracranial aneurysm and arteriovenous malformation.

• Brain tumors with imaging mass effect.

• Macular edema.

• Möbitz type II second-degree/third-degree atrioventricular block or sick sinus syndrome or medical history.

• Systemic infectious disease.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Methylprednisolone
After EVT, intravenous injection of methylprednisolone (Chongqing Lai Mei Pharmaceutical Co., Ltd., 40mg) is recommended with the following specific instructions: administer intravenously at a dose of 2mg/kg (maximum dose of 160mg), administered preoperatively, once daily, for three consecutive days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wan-Jin Chen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality at 90 days		90 days