24 Hours Treatment With Alteplase in Patients With Ischemic Stroke

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The development of intravenous thrombolysis has greatly improved the rate of recanalization and reperfusion in patients with acute ischemic stroke, increasing the proportion of patients with good outcome and reduced mortality. The guideline recommends that patients with ischemic stroke should be treated with intravenous thrombolysis within 4.5 hours. The latest meta-analysis found that ischemic stroke with onset time of 4.5-9 hours with infarction core volume <70ml, ischemic penumbra volume >10ml, and hypoperfusion volume / infarction core volume >1.2 could be benefit from intravenous thrombolysis. The DAWN clinical trial has shown that patients with ischemic stroke with large vessel occlusion with onset time of 6-24 hours could be benefit from endovascular treatment after screening by multi-mode imaging. Therefore, we hypothesize that patients with ischemic stroke with onset time of 4.5-24 hours with a definite penumbra may also benefit from intravenous thrombolysis. The purpose of this study is to explore whether the patients with ischemic stroke with onset time of 4.5-24 hours can benefit from intravenous thrombolysis if they meet the standard of CT perfusion screening.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Fourth Affiliated Hospital of Zhejiang University, School of Medicine; Huzhou Center Hospital; Jiaxing People's Hospital; Jiaxing Second Hospital; Lishui Country People's Hospital; Shaoxing People's Hospital; Zhoushan People's Hospital
• Treatments: Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• Patients presented with clinical signs of acute ischemic stroke between 4.5 and 24 hours of stroke onset or awakening with stroke (if within 24 hours from the midpoint of sleep).

• Patient's age is >18 years.

• NIHSS 4 to 26.

• Imaging inclusion criteria: infarct core volume ≤ 70 mL and penumbra ≥ 10 mL with at least 20% mismatch (as evaluated by CTP).

• Patient, family member or legally responsible person depending on local ethics requirements has given informed consent.

Exclusion Criteria:

• CT shows intracranial hemorrhage or lesions larger than one third of the territory of the middle cerebral artery.

• Pre-stroke mRS score of more than 1 (indicating previous disability);

• Contraindication for alteplase.

• Plan to receive endovascular treatment.

• A life expectancy of less than three months.

• Any condition that could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study (this applies to patients with severe microangiopathy such as hemolytic uremic syndrome or thrombotic thrombocytopenic purpura). The judgment is left to the discretion of the investigator.