Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy (PEARL): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial aiming at evaluating the efficacy and safety of intra-arterial recombinant human tissue plasminogen activator (rt-PA) after successful recanalization of acute large vessel occlusion in the anterior circulation by mechanical thrombectomy in improving the 90-day functional outcome.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Aged 18 years or older.
• Clinical diagnosis of acute ischemic stroke.
• Time from symptom onset to randomization within 24 hours, including wake-up stroke or no-witness stroke; the onset time refers to Last Known Well (LKW).
• CTA or MRA confirmed occlusion of the intracranial segment of the internal carotid artery, or M1 or M2 segment of the middle cerebral artery; stable eTICI score of 2b50-3 after mechanical thrombectomy, with or without intravenous thrombolysis. Patients with an eTICI score of 2b50-3 on the diagnostic cerebral angiography before mechanical thrombectomy are also eligible for the study.
• Baseline NIHSS of 6-25.
• NCCT/DWI-MRI ASPECTS ≥ 6;
• Pre-stroke mRS score ≤ 1, or mRS \>1 but not related to neurological disease (e.g., amputation, blindness).
• Signed informed consent.
Locations
Other Locations
China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
RECRUITING
Guangzhou
Shenzhen Hospital of Southern Medical University
RECRUITING
Shenzhen
Contact Information
Primary
Xinguang Yang
yangxinguang0926@163.com
86-20-81332619
Backup
Xiongjun He
drxjhe@163.com
075523360593
Time Frame
Start Date:2023-08-01
Estimated Completion Date:2025-12
Participants
Target number of participants:324
Treatments
Experimental: Intra-arterial alteplase
Participants in the experimental group will receive a 15-minute continuous infusion of intra-arterial alteplase at a drug concentration of 1.0 mg/ml. 15 minutes after the start of intra-arterial thrombolysis, the infusion will be stopped and an angiogram will be performed to assess the eTICI score. If the angiographic eTICI score improves from the baseline score, the procedure will be terminated, otherwise, a new angiogram will be repeated 5-10 minutes after the end of drug administration.
No_intervention: Standard medical treatment
Participants allocated to the control group will receive standard medical treatment without intra-arterial alteplase after mechanical thrombectomy.