Acute ischemic stroke
Conditions
Interventions
Intervention group:Intravenous thrombolysis + subcutaneous injection of Eryuomid 420 mg (3 syringes, 140 mg each) within 24 hours after thrombolysis + oral Atorvastatin 20 mg/day
Control group:Intravenous thrombolysis + oral atorvastatin 20 mg/day
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-85 years. Male or female, with no gender restrictions. 2. Clinically diagnosed with acute ischemic stroke, with a time from onset to intravenous thrombolysis of less than 9 hours. (1) Within 4.5 hours of onset: This time window is based on the ECASS III criteria (Class IA recommendation), the current standard indication for intravenous thrombolysis in acute ischemic stroke worldwide. (2) 4.5-9 hours: Based on the EXTEND study criteria, multimodal imaging mismatch ratio must be met: ischemic penumbra volume/ischemic core volume >=1.2, absolute mismatch volume >=10 mL, and ischemic core volume =50%, infarct size >1.5 cm + ipsilateral plaque (no stenosis requirement), or intracranial artery stenosis >=30% with plaque ulceration. Moreover, the patient's NIHSS score is between 5 and 20. 4. Informed consent must be signed by the patient or legal representative.
Exclusion criteria
Exclusion criteria: 1. Patients with evidence of intracranial hemorrhage on CT scan, symptomatic intracranial hemorrhage, or symptoms of subarachnoid hemorrhage even if CT scan is normal. 2. Patients who must or wish to continue taking restrictive medications or any medication that may interfere with the safe conduct of the trial. 3. Patients with acute bleeding diathesis, including but not limited to (1) Known genetic predisposition to bleeding, severe bleeding disorders in the current or past 6 months (2) Administered heparin within the past 48 hours and activated partial thromboplastin time (aPTT) exceeding the upper limit of the normal range of laboratory measurements (3) Current use of vitamin K-based oral anticoagulants (e.g., warfarin) and prolonged prothrombin time (INR>=1.7 or PT>=15s) or current use of novel oral anticoagulants (i.e., dabigatran, rivaroxaban, or apixaban) with prolonged aPTT and/or PT above the upper limit of the local laboratory reference range (4) Platelet count less than 100,000/mm^3 at screening (5) Any history of central nervous system damage (i.e., tumor, aneurysm, intracranial or spinal surgery) (6) Traumatic external cardiac massage, obstetric delivery, or non-compressive vascular puncture (e.g., subclavian or jugular vein puncture) within the past 10 days (7) Known history of suspected intracranial hemorrhage or suspected aneurysmal subarachnoid hemorrhage (8) Tumors with increased bleeding risk (9) Documented ulcerative gastrointestinal disease, esophageal varices, aneurysms, arterial/venous malformations within the past 3 months (10) Any condition associated with a significantly increased risk of bleeding 4. Extracranial cervical vascular stenosis >=50% 5. Pre-onset mRS score >=2, concurrent dementia or other disabling neurological conditions 6. Clinically confirmed non-atherosclerotic intracranial arterial stenosis, such as dissection, vasculitis, moyamoya disease, embolism, or immune system disorders 7. Other medical histories that may affect endpoint assessment and follow-up, such as history of brain trauma, multiple sclerosis, encephalitis, tumors, poisoning, syphilis, and severe cardiac, pulmonary, hepatic, renal, or endocrine diseases 8. Pregnant women 9. Currently enrolled in another investigational device or drug study, or receiving other investigational treatment for <30 days since completion 10. Use of PCSK9 inhibitors within 4 weeks prior to enrollment 11. Hypersensitivity to statins or PCSK9 inhibitors 12. Patients with severe hepatic or renal impairment (eGFR <30 ml/min/1.73 m^2) 13. Refusing to sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early Neurological Deterioration (END); | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness: 1. 90-day functional outcome (rate of mRS 0-2 scores and ordinal shift analysis); 2. Stroke recurrence rate;Mechanism Exploration: 1. Dynamic changes in serum levels of PCSK9, hsCRP, IL-6, S100ß, and NSE from baseline to 36 h and 72 h; 2. Correlation between the changes in the above biomarkers and END.;Impact of onset-to-thrombolysis time (<4.5 h vs. 4.5–9 h) on the primary efficacy endpoint;Safety Endpoints: 1. Symptomatic intracerebral hemorrhage (sICH, defined by the SITS-MOST criteria); 2. All-cause mortality (up to day 90); 3. Other adverse events.; | — |
Countries
China
Contacts
Public ContactFeng Yu
Xuzhou Medical College Affiliated Hospital
Outcome results
None listed