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Recruiting Phase 3 NCT05856851

Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy

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Trial Parameters

Condition Stroke, Acute Ischemic
Sponsor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 324
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-08-01
Completion 2025-12
Interventions
Alteplase

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Brief 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 Criteria

Inclusion Criteria: 1. Aged 18 years or older. 2. Clinical diagnosis of acute ischemic stroke. 3. 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). 4. 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. 5. Baseline NIHSS of 6-25. 6. NCCT/DWI-MRI ASPECTS ≥ 6; 7. Pre-stroke mRS score ≤ 1, or mRS \>1 but not related to neurological disease (e.g., amputation, blindness). 8. Signed informed consent. Exclusion Criteria: 1. Contraindication to rt-PA (except time to therapy). 2. Planned use of dual antiplatelet therapy within the first 24 hours after mechanical t

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