A Study of r-PA Treating Patients With Acute Ischemic Stroke（RAISE）

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of recombinant human tissue plasminogen kinase derivatives for injection and alteplase in the treatment of patients with acute ischemic stroke within 4.5 hours.

Clinical Trial Description

This study is a multicenter, randomized, blind endpoint and positive drug control study. The study plans to recruit 1412 AIS patients within 4.5 hours of onset. Qualified subjects are assigned to the test drug and control drug alteplase group according to the ratio of 1:1. After receiving thrombolytic drugs, the subjects need to carry out a series of safety and effectiveness tests. The mRS score and Barthel index score visits are carried out on the 90th day (± 7 days) after thrombolysis. After the visit, the subjects can leave the group. In this study, independent blind endpoint evaluators were set up in each research center to evaluate the mRS and Barthel index score 30 and 90 days after thrombolysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05295173
Study type	Interventional
Source	Angde Biotech Pharmaceutical Co., Ltd.
Contact
Status	Completed
Phase	Phase 3
Start date	March 21, 2022
Completion date	June 22, 2023

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See also
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