Actively Recruiting
HRS-7450 Injection Phase II Clinical Trial for Acute Ischemic Stroke.
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2025-11-20
208
Participants Needed
2
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HRS-7450 Injection Phase II Clinical Trial for Acute Ischemic Stroke.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily agree to participate and provide informed consent
- Age between 18 and 80 years inclusive
- Stroke symptom onset within 4.5 to 24 hours
- Clinically diagnosed with acute ischemic stroke
- Pre-stroke modified Rankin Scale score less than 2
- NIH Stroke Scale score between 6 and 25 at screening
- Meet specific imaging criteria
- Use effective contraception if of childbearing potential or have a partner who is
You will not qualify if you...
- Received thrombolytic therapy
- Planned to undergo endovascular therapy
- Arterial dissection in head, neck, or aorta
- Multiple infarctions in several large brain vessels
- NIH Stroke Scale level of consciousness item 1a score greater than 2
- Neurological problems due to seizure or other conditions preventing cooperation
- Large hypodense area in middle cerebral artery territory on CT scan
- Intracranial tumor, arteriovenous malformation, or giant aneurysm
- History of intracranial bleeding diseases
- Recent ischemic stroke, severe head trauma, or brain/spinal surgery within 3 months
- Recent significant internal bleeding within 3 weeks
- Major surgery or severe trauma within 2 weeks
- Recent arterial puncture at non-compressible site within 1 week
- Uncontrolled high blood pressure despite treatment
- Known bleeding or clotting disorders
- Abnormal blood glucose levels at screening
- Recent serious heart conditions or hospitalizations
- Significant liver disease or abnormal liver tests
- Severe kidney disease or low kidney function
- History of hemolytic anemia under treatment or unresolved
- Allergy to HRS-7450 or its components
- Recent use of therapeutic heparin or oral anticoagulants
- Use of glycoprotein IIb/IIIa inhibitors recently
- Pregnant or breastfeeding women or positive pregnancy test
- Participation in another drug or device trial within 3 months
- Terminal illness with life expectancy under 1 year
- Any other condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510062
Actively Recruiting
2
Linyi People's Hospital
Linyi, Shandong, China, 276002
Actively Recruiting
Research Team
Y
Yu Gao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here