About this trial
This study is designed to determine the efficacy and safety of SHPL-49 intravenous infusion in acute ischemic stroke patients.
Eligibility criteria
Qualifiers
Age 18-80 years old (including upper and lower limits);
Clinically diagnosed as acute ischemic stroke according to the latest guidelines;
Patients diagnosed as acute ischemic stroke who plan to receive or have received standard intravenous thrombolysis in hospital (this research center) within 8hours of symptom onset;
Patients who have NIHSS score≥5 and ≤ 22 before thrombolysis;
Disqualifiers
Complicated with intracranial hemorrhagic diseases, including hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.;
Severe disturbance of consciousness: patients with NIHSS 1a consciousness level item score ≥2;
Cerebral Computed tomography (CT) or Magnetic resonance imaging (MRI) indicated a large anterior circulation cerebral infarction (infarct area greater than 1/3 of the middle cerebral artery blood supply area);
Stroke with rapid improvement of symptoms before intravenous thrombolysis, or acute ischemic symptoms suspected to be caused by other causes;
Trial design
Treatments tested in this trial
- SHPL-49 Injection
- Placebo Injection
Treatment groups
Sponsors and collaborators
Shanghai Hutchison Pharmaceuticals Limited
Lead sponsor
Beijing Tiantan Hospital
Collaborator