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Study on the Effectiveness and Safety of Nitrone for Injection in Patients With Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:
Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Trial to Evaluate the Effectiveness and Safety of Nitrone for Injection in Patients With Acute Ischemic Stroke

Clinical Trial Summary

The main purpose of the study: To evaluate the effect of nitrosone 1 special for patients with acute ischemic cerebral stroke. The secondary purpose of the study: To evaluate the effectiveness of the injection of nitrosone I. T for loyal patients with acute ischemic stroke All women think.

Clinical Trial Description

The main purpose of the study: To evaluate the effect of nitrosone 1 special for patients with acute ischemic cerebral stroke. The secondary purpose of the study: To evaluate the effectiveness of the injection of nitrosone I. T for loyal patients with acute ischemic stroke All women think. This experiment adopts randomized, double-blind, placebo-controlled parallel design. In patients with acute, ischemic cerebral rate as the research object, after selected exclusion standard screening, if doesn't fit or don't agree with thrombolysis subjects, giving from connect to test a drug or a placebo treatment, if appropriate and agreed to thrombolysis of the subjects with an experimental drug or placebo after thrombolysis treatment.Intervention group: 30) min uniform given 1400 mg intravenous drip injection with ketone wordy, nitrate dosing volume 100 ml. Day delivery, two intervals of 12 h, for seven days in a row, namely to 14 times in total.The placebo group: 30 min to 100 ml placebo at a constant speed intravenous drip (sodium chloride injection), dosing W times a day, 12 h, for seven days in a row, namely to 14 times in total.During treatment, participants in the group after injection with nitrate ketone oxazine (giving injections with nitrate ketone oxazine time window < 6 h, that is, from "the last look normal time" to start infusion nitrate obviously time) or placebo and other foundation treatment. Record for the first time to give the time of nitrate ketone oxazine or placebo for injection, lie between 8 and 12 h 2 times to medicine."After 12 h dosing interval, until finish to 14 times (for convenient subjects out of the hospital and acceptable to 13).Allow this study drug and placebo and thrombolysis drug dosing dual channel at the same timeStop to test drug or placebo, in the group of 8 days, 14 days, 30 days, the 90th day to evaluate curative effect, respectively.In the I the ili is not ah into subgroups according to try tii statistical treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04951440
Study type Interventional
Source Peking University Third Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date June 1, 2018
Completion date December 1, 2021
View Details
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