Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy (NCT05856851) | Clinical Trial Compass
CompletedPhase 3
Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy
China324 participantsStarted 2023-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The modified Rankin Scale score (mRS) 0-1
Timeframe: 90(±7) days
Trial details
NCT IDNCT05856851
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
. Pre-stroke mRS score ≤ 1, or mRS \>1 but not related to neurological disease (e.g., amputation, blindness).
. Signed informed consent.
Exclusion criteria
. 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.
. Women who are pregnant or breastfeeding.
. Participation in other clinical trials.
. Preoperative intracranial hemorrhage confirmed by cranial CT or MRI.
. Known genetic or acquired bleeding disposition with anticoagulation factor deficiency.