Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy
NCT ID: NCT05856851
Last Updated: 2024-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
324 participants
INTERVENTIONAL
2023-08-01
2025-12-31
Brief Summary
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Detailed Description
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Study intervention: (1) Participants in the experimental group will receive intra-arterial alteplase (a dose of 0.225 mg/kg and a maximum dose of 20 mg) after the mechanical thrombectomy, and will receive standard medical treatment after the procedure. (2) Participants in the control group will receive standard medical treatment without intra-arterial alteplase.
A total of 324 participants are anticipated to be recruited for this study, with 162 participants in each group (1:1 ratio).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intra-arterial alteplase
Participants in the experimental group will receive a 15-minute continuous infusion of intra-arterial alteplase at a drug concentration of 1.0 mg/ml. 15 minutes after the start of intra-arterial thrombolysis, the infusion will be stopped and an angiogram will be performed to assess the eTICI score. If the angiographic eTICI score improves from the baseline score, the procedure will be terminated, otherwise, a new angiogram will be repeated 5-10 minutes after the end of drug administration.
Alteplase
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Standard medical treatment
Participants allocated to the control group will receive standard medical treatment without intra-arterial alteplase after mechanical thrombectomy.
No interventions assigned to this group
Interventions
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Alteplase
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Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Planned use of dual antiplatelet therapy within the first 24 hours after mechanical thrombectomy.
3. 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.
4. Suspected cerebral vasculitis based on medical history and/or angiographic evaluation.
5. Women who are pregnant or breastfeeding.
6. Participation in other clinical trials.
7. Preoperative intracranial hemorrhage confirmed by cranial CT or MRI.
8. Known genetic or acquired bleeding disposition with anticoagulation factor deficiency.
9. Coagulation disorder with INR \> 1.7 or use of new oral anticoagulants (within 48 hours of symptom onset).
10. Platelet count \<50X10\^9/L.
11. Suspected vascular occlusion as a result of infective endocarditis.
12. Known severe renal insufficiency with glomerular filtration rate \<30 ml/min or blood creatinine \>220 μmol/L (2.5 mg/dl).
13. Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast.
14. Suspected aortic dissection.
15. Previous parenchymal organ surgery or biopsy in the last 1 month;
16. Any active bleeding or recent bleeding (gastrointestinal, urinary tract bleeding, etc.) in the last 1 month;
17. SBP \> 185 mmHg or DBP \> 110 mmHg refractory to treatment.
18. Anticipated life expectancy \< 6 months (e.g., malignancy, severe cardiopulmonary disease, etc.).
19. 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).
18 Years
ALL
No
Sponsors
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Shenzhen Hospital of Southern Medical University
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Principal Investigators
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Yamei Tang
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Yajie Liu
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Hospital of Southern Medical University
Locations
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Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Yang X, He X, Pan D, Xu Y, Peng H, Li K, Zhang M, Zhu Y, Chen Y, He B, Zhou H, Li J, Hou H, Sun H, Liu Y, Tang Y. Intra-arterial alteplase for acute ischaemic stroke after mechanical thrombectomy (PEARL): rationale and design of a multicentre, prospective, open-label, blinded-endpoint, randomised controlled trial. BMJ Open. 2024 Nov 5;14(11):e091059. doi: 10.1136/bmjopen-2024-091059.
Other Identifiers
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SYSKY-2023-390-02
Identifier Type: -
Identifier Source: org_study_id
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