Tangdu Hospital
Xi'an, Shaanxi, 710038, China
Location status: Recruiting
NCT Number: NCT07141303
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 3
Xi'an, Shaanxi, 710038, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 patients will receive intra-arterial and intravenous sterile water for injection.
Time frame: 90 days
Time frame: 48 hours
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 1 year
Time frame: within 48 hours
Time frame: 5-7 days after surgery
Time frame: 90 days
Time frame: 1 year
Time frame: within 48 hours after treatment
Time frame: within 7 days after the treatment
Time frame: within 7 days after treatment
Time frame: within 7 days after treatment
Contact information is provided by the study sponsor or research team.
Tang-Du Hospital
Other
Acronym: IMPACT-LVO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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