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

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

Interventions

DRUG

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.

DRUG

Placebo

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

Sponsors & Collaborators

• The First people's hospital of Xian Yang

  collaborator UNKNOWN

• First People's Hospital Of Tianshui

  collaborator UNKNOWN

• XD Group Hospital

  collaborator UNKNOWN

• Xi'an Aerospace General Hospital

  collaborator UNKNOWN

• First Affiliated Hospital of Chengdu Medical College

  collaborator OTHER

• Tang-Du Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-08

Primary Completion

2027-12-31

Completion

2028-06-30

Countries

• China

Study Locations