Acute Ischemic Stroke Clinical Trial
Official title:
A PhaseⅡ, Multicenter, Prospective Randomised, Open Blinded Endpoint Study to Evaluate Safety and Efficacy of Injection for Recombinant Human Tissue Plasminogen Kinase Derivative in Treatment of Acute Ischemic Stroke.
The primary purpose of this trial is to compare the efficacy of different doses of
investigator product and comparator product in patients with acute ischemic stroke in 4.5
Hours after stroke onset, and provide a basis of drug administration for phase Ⅲ clinical
trial.
The secondary purpose of this trial is to compare the safety of different dose of
investigational product and comparator product in patients with acute ischemic stroke in 4.5
hours afterstroke onset .
This study is a multicenter, prospective randomised, open blinded endpoint study.
Patients with acute ischemic stroke need to undergo CT or MRI to exclude intracranial
hemorrhage and perform NIHSS score before enrollment. Subjects who have passed the screening
criteria according to the inclusion and exclusion criteria will be randomly assigned to
low-dose test drugs, high-dose test drugs or reference drugs for thrombolytic therapy at a
ratio of 1:1:1. The random stratification factor is the thrombolysis time window ("≤3h" vs
"3~4.5h").
The start of administration of the study drug is recorded as 0h, CT or MRI and NIHSS score,
laboratory test, and electrocardiogram were performed at 24 hours; NIHSS score was performed
at 72 hours; NIHSS score，laboratory test and electrocardiogram were performed on the14th
day(the start of administration is recorded as Day 1 ,then the 14th day after administration
should be recorded as Day 15 ); mRS score and Barthel index score were performed on the 30th
day (Day 31); mRS score and Barthel index score were performed on the 90th day (Day 91).
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