EXtending the Time Window for Thrombolysis in Posterior Circulation Stroke Without Early CT Signs

• Status: Not yet recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary hypothesis being tested in this trial is that ischemic stroke patients in posterior circulation at 4.5 - 24 hours post onset of stroke will have improved clinical outcomes when given intravenous tissue plasminogen activator (tPA) compared to standard care.

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

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Treatments: Plasminogen; 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 between 4.5 and 24 hours from the midpoint of sleep).

• Patient's age is > 18 years (or as per local requirements).

• NIHSS ≥ 1.

• Patients with post circulation ASPECT score ≥ 7.

• Patients meet at least one of the below criteria: post circulation stroke considered by experienced clinicians, or infarction of posterior circulation confirmed by MRI within 1 hour before or post CT, or the vascular examination indicates that there are symptomatic stenosis or occlusion of large posterior circulation vessels, or the perfusion image indicates that there are symptomatic hypoperfusion changes in the posterior circulation area.

• Pre-stroke mRS score < 2.

• Patients do not receive endovascular treatment at patients' and treating clinician's discretion

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

Exclusion Criteria:

• Contraindication for alteplase.

• A life expectancy of less than three months.

• The judgment is left to the discretion of the investigator.