Intra-arterial Methylprednisolone After Endovascular Thrombectomy

Official title

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

Overview

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.

Interventions

• Drug The methylprednisolone sodium succinate group
  Intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days.
• Drug The placebo group
  The placebo group patients will receive intra-arterial and intravenous sterile water for injection.

Primary outcome measures

• Incidence of symptomatic intracranial hemorrhage [Time frame: 48 hours]
• Mortality [Time frame: 90 days]

Secondary outcome measures (10)

• Shift in the distribution of mRS scores [Time frame: 90 days]
• 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 [Time frame: 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. [Time frame: within 7 days after EVT.]
• 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 [Time frame: 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 [Time frame: within 48 hours]
• EQ-5D scale score at 90 days [Time frame: at 90 days]

Eligibility criteria

Inclusion criteria

• Age 18-80 years old;
• The time from onset to randomization was within 24 hours;
• 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;
• NIHSS score >= 6 points
• Alberta Stroke Program Early Diagnosis (ASPECTS) score of NCCT >=3;
• Successful endovascular thrombectomy (eTICI 2b50-3)
• Written informed consent signed by patients or their family members

Exclusion criteria

• Intracranial hemorrhage confirmed by computed tomography (CT) or magnetic resonance imaging (MRI);
• Prestroke mRS score >= 2
• pregnant or lactating patients
• Allergy to iodinated contrast media, or methylprednisolone sodium succinate
• Participating in other clinical research;
• Inherited/acquired hemorrhagic diathesis (coagulation factor deficiency) or oral anticoagulation with international normalized ratio (INR) >1.7
• History of major bleeding within the past 1 month (gastrointestinal/genitourinary hemorrhage)
• Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate < 30ml/min/1.73m\^2 or serum creatinine > 220μmol/L (2.5mg/dl));
• Terminal illness with life expectancy <6 months;
• Blood glucose < 2.8mmol/L (50mg/dl) or > 22.2mmol/L (400mg/dl);
• Intracranial aneurysm, arteriovenous malformation, or space-occupying brain tumor with mass effect on imaging
• Active systemic infectious disease
• Anticipated inability to complete follow-up
• Intraoperative DSA showed vascular perforation, dissection, and contrast extravasation;
• Puncture to recanalization was more than 90 minutes;
• Total thrombectomy passes >3

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Tangdu Hospital — Xi'an

Identifiers

NCT: NCT07516522 · K202602-29

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗