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 = 178 patients (n=89 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 15% non-adherence rate (due to loss to follow-up, consent withdrawal and other reasons), we planned to enrol n=210 patients (n=105 per group) for this study. The findings of IMPACT-LVO are likely to have a direct impact on clinical practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
210
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.
Tangdu Hospital
Xi'an, Shaanxi, China
RECRUITINGIncidence of symptomatic intracranial hemorrhage
Incidence of symptomatic intracranial hemorrhage
Time frame: 48 hours
Mortality
Mortality
Time frame: 90 days
Shift in the distribution of mRS scores
Shift in the distribution of mRS scores
Time frame: 90 days
Proportion of patients with any radiologic intracranial haemorrhage within 48 hours after treatment
Proportion of patients with any radiologic intracranial haemorrhage within 48 hours after treatment
Time frame: within 48 hours after treatment
Proportion of patients with pneumonia within 7 days after EVT
Proportion of patients with pneumonia within 7 days after EVT
Time frame: within 7 days after EVT
Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT;
Proportion of patients with gastrointestinal haemorrhage within 7 days after EVT;
Time frame: within 7 days after EVT;
Incidence of serious adverse events within 7 days after EVT.
Incidence of serious adverse events within 7 days after EVT.
Time frame: within 7 days after EVT.
The proportion of mRS score 0 to 4 at 90 days
The proportion of mRS score 0 to 4 at 90 days
Time frame: at 90 days
The proportion of mRS score 0 to 3 at 90 days
The proportion of mRS score 0 to 3 at 90 days
Time frame: at 90 days
The proportion of mRS score 0 to 2 at 90 days
The proportion of mRS score 0 to 2 at 90 days
Time frame: at 90 days
The incidence of malignant brain edema within 48 hours
The incidence of malignant brain edema within 48 hours
Time frame: within 48 hours
EQ-5D scale score at 90 days
EQ-5D scale score at 90 days
Time frame: at 90 days
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