Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy

Recruiting now · Phase 3

Conditions studied: Stroke, Acute Ischemic

In brief

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.

Key facts

Study ID

NCT05856851

Run by

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

People needed

324

Starts

2023-08-01

Expected to finish

2025-12-01

Last updated by the study team

2024-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Coagulation disorder with INR > 1.7 or use of new oral anticoagulants (within 48 hours of symptom onset).
• Platelet count <50X10\^9/L.
• Suspected vascular occlusion as a result of infective endocarditis.
• Known severe renal insufficiency with glomerular filtration rate <30 ml/min or blood creatinine >220 μmol/L (2.5 mg/dl).
• Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast.
• Suspected aortic dissection.
• Previous parenchymal organ surgery or biopsy in the last 1 month;
• Any active bleeding or recent bleeding (gastrointestinal, urinary tract bleeding, etc.) in the last 1 month;
• SBP > 185 mmHg or DBP > 110 mmHg refractory to treatment.
• Anticipated life expectancy < 6 months (e.g., malignancy, severe cardiopulmonary disease, etc.).
• Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).

Where it is running

• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (enrolling)
• Shenzhen Hospital of Southern Medical University — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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