Clinical Study of Cinepazide Maleate Injection in the Treatment of Acute Ischemic Stroke

Stroke, Ischemic Clinical Trial

Official title: Cinepazide Maleate Injection in the Treatment of Acute Ischemic Stroke A Blind, Multicenter, Placebo-controlled Clinical Confirmatory Study.

Status Completed

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel controlled, post marketing confirmatory clinical trial in Chinese patients with acute ischemic stroke. Objective to evaluate the efficacy and safety of cinepazide maleate injection compared with placebo in the treatment of patients with acute ischemic stroke.

Clinical Trial Description

The target population of this study is patients with acute ischemic stroke within 48 hours. All potential participants must provide informed consent, and those who provide informed consent will enter the screening (- 48 ~ 0h), and the screening qualification will be evaluated according to the inclusion criteria. The eligible subjects will enter the treatment period (day 1-14) and will be randomly assigned to the experimental group (cinepazide maleate injection group) or the control group (placebo group).

During the treatment period, all subjects will receive cinepazide maleate injection or placebo by intravenous drip at the rate of 100ml / h, once a day for 14 consecutive days. During the treatment, all subjects need to receive basic treatment: citicoline sodium injection 0.5g, dissolved in 5% glucose injection or normal saline 250ml, intravenous drip slowly, once a day, continuous administration for 10 days. According to the Chinese guidelines for the diagnosis and treatment of acute ischemic stroke (2014), the patients were given antihypertensive, hypoglycemic, lipid-lowering, anticoagulant or mannitol. All subjects were not allowed to receive interventional therapy, thrombolysis (such as rtPA and urokinase), defibrillator, any platelet inhibitor except aspirin and clopidogrel, other cerebrovascular dilators (such as cinnarizine, flunarizine, nicardipine and nimodipine), other neuroprotective agents (except citicoline) during the whole trial period After the end of the treatment period (the 14th day), the subjects will enter the follow-up period (the 15th-90th day).

During the follow-up period, subjects need to be followed up twice (30th day) ± 2 days, 90th day ± 3 days). ;

Related Conditions & MeSH terms

• Ischemia
• Stroke
• Stroke, Ischemic

• NCT number: NCT04951232
• Study type: Interventional
• Source: Peking University Third Hospital
• Status: Completed
• Phase: N/A
• Start date: July 4, 2016
• Completion date: January 6, 2017