NCT05295173

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

A Phase III, Multicenter, Randomized, Blind Endpoint and Positive Drug Control Study of Recombinant Human Tissue Plasminogen Kinase Derivatives for Injection in the Treatment of Patients With Acute Ischemic Stroke

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,412 (actual)
• Sponsor: Angde Biotech Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Injection of recombinant human tissue plasminogen kinase derivatives	18mg/10ml/stick, provided by Angde Biotech
DRUG	Recombinant human tissue plasminogen activator	20mg/stick, 50mg/stick, provided by Shanghai Boehringer Ingelheim Pharmaceutical Co. Ltd.

Timeline

• Start date: 2022-03-21
• Primary completion: 2023-06-22
• Completion: 2023-06-22
• First posted: 2022-03-25
• Last updated: 2024-03-04

Locations

78 sites across 1 country: China