Phase III Clinical Trial of SHPL-49 Injection in the Treatment of Acute Ischemic Stroke

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Hutchison Pharmaceuticals Limited

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

1,096 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shanghai Hutchison Pharmaceuticals Limited

Lead sponsor

Beijing Tiantan Hospital

Collaborator