Intra-arterial Methylprednisolone After Successful Endovascular Thrombectomy Anterior Circulation Large Vessel Occlusion

NCT ID: NCT07141303

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1060 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-08
• Study Completion Date: 2028-06-30

Brief Summary

The purpose of IMPACT-LVO trial is to investigate the efficacy and safety of early adjunctive intra-arterial combined with intravenous administration methylprednisolone sodium succinate after successful endovascular thrombectomy in anterior circulation large vessel occlusion patients.

This is a multicenter, randomized, double-blind, placebo-controlled trial. Acute ischemia stroke patients with anterior circulation large vessel occlusion within 24 hours from last known well will be screened for this trial. Successful recanalization after mechanical thrombectomy (eTICI 2b-3) patients will be randomized 1:1 to either methylprednisolone sodium succinate group or placebo group. The methylprednisolone sodium succinate group patients will receive intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days. The placebo group patients will receive intra-arterial and intravenous sterile water for injection.

The shift on modified Rankin Scale score is designed to detect in the present trial. A sample size of n = 1010 patients (n=505 per group) is required. The intention-to-treat principle will be applied to the primary analysis, therefore, to safeguard against dilution of the treatment effect associated with an approximate 5% non-adherence rate (due to loss to follow-up, consent withdrawal and other reasons), we planned to enrol n=1060 patients (n=530 per group) for this study. The findings of IMPACT-LVO are likely to have a direct impact on clinical practice.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

The methylprednisolone sodium succinate group

The methylprednisolone sodium succinate group patients will receive intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days.

Group Type: EXPERIMENTAL

The methylprednisolone sodium succinate

Intervention Type: DRUG

Patients will receive intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization from thrombectomy in anterior circulation large vessel occlusion. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days.

The placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The placebo group patients will receive intra-arterial and intravenous sterile water for injection.

Interventions

The methylprednisolone sodium succinate

Patients will receive intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization from thrombectomy in anterior circulation large vessel occlusion. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days.

Intervention Type: DRUG

Placebo

The placebo group patients will receive intra-arterial and intravenous sterile water for injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 18-80 years old; 2) The time from onset to randomization was within 24 hours; 3) Large vessel occlusive stroke in the anterior circulation confirmed by CTA/MRA/DSA (Including intracranial segment of internal carotid artery, M1 or M2 segment of middle cerebral artery) and the vessel responsible for the signs and symptoms of acute ischemic stroke; 4) NIHSS score >= 6 points 5) Alberta Stroke Program Early Diagnosis (ASPECTS) score of NCCT >=3; 6) Successful endovascular thrombectomy (eTICI 2b50-3) 7) Written informed consent signed by patients or their family members

Exclusion Criteria

1. Intracranial hemorrhage confirmed by computed tomography (CT) or magnetic resonance imaging (MRI);

2. Prestroke mRS score >= 2

3. pregnant or lactating patients

4. Allergy to iodinated contrast media, or methylprednisolone sodium succinate

5. Participating in other clinical research;

6. Inherited/acquired hemorrhagic diathesis (coagulation factor deficiency) or oral anticoagulation with international normalized ratio (INR) >1.7

7. History of major bleeding within the past 1 month (gastrointestinal/genitourinary hemorrhage)

8. Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate < 30ml/min/1.73m^2 or serum creatinine > 220μmol/L (2.5mg/dl));

9. Terminal illness with life expectancy <6 months;

10. Blood glucose < 2.8mmol/L (50mg/dl) or > 22.2mmol/L (400mg/dl);

11. Intracranial aneurysm, arteriovenous malformation, or space-occupying brain tumor with mass effect on imaging

12. Active systemic infectious disease

13. Anticipated inability to complete follow-up

14. Intraoperative DSA showed vascular perforation, dissection, and contrast extravasation;

15. Puncture to recanalization was more than 90 minutes; Total thrombectomy passes >3

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First people's hospital of Xian Yang

UNKNOWN

Sponsor Role: collaborator

First People's Hospital Of Tianshui

UNKNOWN

Sponsor Role: collaborator

XD Group Hospital

UNKNOWN

Sponsor Role: collaborator

Xi'an Aerospace General Hospital

UNKNOWN

Sponsor Role: collaborator

First Affiliated Hospital of Chengdu Medical College

OTHER

Sponsor Role: collaborator

Tang-Du Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tangdu Hospital

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Guo, MD

Role: CONTACT

18729985168@163.com

0086-18729985168

Facility Contacts

Wei Guo, MD

Role: primary

18729985168@163.com

0086-18729985168

Other Identifiers

K202508-15

Identifier Type: -

Identifier Source: org_study_id