Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy
Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy (PEARL): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
324 participants
Aug 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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.
Exclusion Criteria19
- 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).
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Interventions
See arm/group descriptions.
Locations(2)
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NCT05856851