Efficacy and Safety of Butylphthalide for Acute Ischemic Stroke Patients Receiving Intravenous Thrombolysis or Endovascular Treatment

Summary

Participation Requirements

Description

This trial is a prospective, randomized, double-blinded, placebo parallel controlled, multiple-center trial. A total of approximately 1200 patients (Age?18years) within 6 hours of symptom onset of acute ischemic stroke, who shows NIHSS from 4-25 points and intend to be treated with iv-rtPA and/or me...

This trial is a prospective, randomized, double-blinded, placebo parallel controlled, multiple-center trial. A total of approximately 1200 patients (Age?18years) within 6 hours of symptom onset of acute ischemic stroke, who shows NIHSS from 4-25 points and intend to be treated with iv-rtPA and/or mechanical thrombectomy will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content, meanwhile the first injection will be within 6 hours from stroke onset : 1) one group will receive Butylphthalide and Sodium Chloride Injection 100ml twice/day in the initial 14 days, then take Butylphthalide Soft Capsules 0.2g triple/day for the rest 15th to 90th day therapy; 2) the other group will receive Butylphthalide Placebo Injection 100ml twice/day in the initial 14 days and then take Butylphthalide Placebo Soft Capsules 0.2g triple/day for the rest 15th to 90th day therapy. The primary objective is to explore whether the dl-NBP can improve the proportion of patients with a favorable outcome after receiving iv-rtPA and/or mechanical thrombectomy. The study consists of four visits including the day of randomization, 2 days after the first injection, 14 days when the injection therapy is done, and 30, 60 and 90 days when the oral therapy is finished. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The favorable outcome based on the 90-day modified Rankin Scale score was adjusted for baseline stroke severity, which was defined as a modified Rankin Scale score of 0 in patients with a baseline NIHSS core of 4 to 7, a modified Rankin Scale score of 0 to 1 in patients with a baseline NIHSS score of 8 to 14, and a modified Rankin Scale score of 0 to 2 in patients with a baseline NIHSS score of 15 to 25. The trial is anticipated to last from June 2018 to December 2022 with 1200 subjects recruited form 36 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee(EC) in Being Tiantan hospital, Capital Medical University.

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