Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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

Qualifiers

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.

Disqualifiers

Contraindication to rt-PA (except time to therapy).

Planned use of dual antiplatelet therapy within the first 24 hours after mechanical thrombectomy.

Angiographic evaluation showing dissection, severe stenosis, or complete occlusion of the carotid artery, which requires the use of carotid artery stents during the endovascular procedure.

Suspected cerebral vasculitis based on medical history and/or angiographic evaluation.

Trial design

Treatments tested in this trial

  • Alteplase

Treatment groups

324 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Lead sponsor

Shenzhen Hospital of Southern Medical University

Collaborator