Actively Recruiting
Phase III Clinical Trial of SHPL-49 Injection in the Treatment of Acute Ischemic Stroke
Led by Shanghai Hutchison Pharmaceuticals Limited · Updated on 2026-01-06
1096
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
S
Shanghai Hutchison Pharmaceuticals Limited
Lead Sponsor
B
Beijing Tiantan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is designed to determine the efficacy and safety of SHPL-49 intravenous infusion in acute ischemic stroke patients.
CONDITIONS
Official Title
Phase III Clinical Trial of SHPL-49 Injection in the Treatment of Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old
- Clinically diagnosed with acute ischemic stroke according to the latest guidelines
- Received or plan to receive standard intravenous thrombolysis within 8 hours of symptom onset
- NIHSS score between 5 and 22 before thrombolysis
- Pre-stroke Modified Rankin Scale score of 0 or 1
- Able and willing to provide informed consent personally or via a legal representative
You will not qualify if you...
- Presence of intracranial hemorrhagic diseases such as hemorrhagic stroke or hematomas
- Severe disturbance of consciousness with NIHSS consciousness level item score of 2 or higher
- Large anterior circulation cerebral infarction indicated by imaging (>1/3 middle cerebral artery area)
- Rapid symptom improvement before thrombolysis or symptoms caused by other reasons
- Received or planned endovascular therapy
- Use of neuroprotective drugs after stroke onset
- History of atrial fibrillation, deep vein thrombosis, pulmonary embolism requiring anticoagulants
- Severe hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg despite treatment)
- Severe renal insufficiency or failure
- Severe liver impairment or active liver diseases
- Heart function above Class II or history of congestive heart failure
- Malignant tumors or receiving anti-tumor therapy
- Allergic to study drugs or imaging materials
- Pregnant, breastfeeding, or planning pregnancy
- History of epilepsy, seizures at stroke onset, serious mental disorders, intellectual disabilities, or dementia
- Alcohol dependence or heavy drinking before stroke onset
- Participation in other clinical studies within 3 months before consent
- Severe head trauma or stroke within past 3 months
- Severe systemic diseases with life expectancy under 90 days
- Judged unsuitable by investigators for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Linfen Central Hospital
Linfen, Shanxi, China, 041000
Actively Recruiting
Research Team
W
Wenwen Xu, Master
CONTACT
X
Xiaoling Zhao, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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