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Active Not Recruiting NCT07233070

HRS-7450 Injection Phase II Clinical Trial for Acute Ischemic Stroke.

Conditions: Acute Ischemic Stroke

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 210
Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Location: The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong

Summary

This study plans to enroll a total of 208 patients with Acute Ischemic Stroke (AIS) who present within 4.5 to 24 hours of symptom onset and meet the specified imaging criteria.

Eligibility Criteria

Inclusion Criteria: 1. Fully understand and voluntarily participate in this study, and sign the informed consent form; 2. Aged between 18 and 80 years inclusive (18 ≤ age ≤ 80), regardless of gender; 3. Onset of symptoms within 4.5 to 24 hours; 4. Clinically diagnosed with acute ischemic stroke; 5. Pre-stroke modified Rankin Scale (mRS) score \< 2; 6. National Institutes of Health Stroke Scale (NIHSS) score between 6 and 25 (inclusive) at screening; 7. Meet the imaging inclusion criteria; 8. Female subjects of childbearing potential and male subjects with partners of childbearing potential must use highly effective contraception and avoid sperm/ova donation. Exclusion Criteria: 1. Treatment with thrombolytic therapy. 2. Planned endovascular therapy. 3. Arterial dissection of the head, neck, or aorta. 4. Multiple infarctions across multiple large vascular territories. 5. NIHSS level of consciousness item 1a score \> 2. 6. Neurological deficits presenting after a seizure or post-ictal state, or the presence of other neurological conditions leading to uncooperative or unwillingness to cooperate with examination. 7. Hypodensity exceeding one-third of the middle cerebral artery (MCA) territory on non-contrast CT scan. 8. Intracranial tumor, arteriovenous malformation (AVM), or giant aneurysm. 9. History of intracranial hemorrhagic disease, including but not limited to intracerebral hemorrhage, subarachnoid hemorrhage, etc. 10. History of ischemic stroke, severe head trauma, or intracranial/intraspinal surgery within the past 3 months. 11. Visceral bleeding within the past 3 weeks, including but not limited to gastrointestinal or genitourinary bleeding. 12. Major surgery or severe trauma within the past 2 weeks. 13. Arterial puncture at a non-compressible site within the past week. 14. Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥100 mmHg despite aggressive antihypertensive treatment. 15. Known significant bleeding tendency or severe coagulation disorder. 16. Blood glucose at screening \>22.2 mmol/L or \ 520 ms, and/or hospitalization for acute coronary syndrome, MI, cardiac arrest, or unplanned coronary intervention; or New York Heart Association (NYHA) Class III/IV heart failure; or known ventricular tachycardia. 18. Significant liver disease history, or AST and/or ALT and/or GGT ≥3 × ULN, and/or total bilirubin (TBIL) ≥2 × ULN, or known congenital disorder of bilirubin metabolism. 19. Clinically significant severe renal disease, or estimated glomerular filtration rate (eGFR) \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07233070). StuddyBuddy aggregates publicly available trial information.