Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Nanjing Yoko Biomedical

Status and phase: Suspended; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Drug: Compound Edaravone Injection-High dose; Drug: Edaravone Injection; Drug: Compound Edaravone Injection-Low dose; Drug: Placebo injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04984577

NJYK-CPEDRV-II

Details and patient eligibility

About

The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospitalized patients, diagnosed of ischemic stroke;
• Onset of stroke is less than or equal to 48 hours;
• There are clear signs of neurological deficit: 4≤NIHSS score≤24, and also, the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;
• Patients signed written inform consent

Exclusion criteria

• Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;
• Iatrogenic stroke;
• Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1；
• The mRS score prior to this onset is greater than 1;
• Transient ischemic attack (TIA);
• SBP after blood pressure control is still greater than or equal to 220 mmHg, or DBP after blood pressure control is still greater than or equal to 120 mmHg;
• Patients with severe mental disorders and dementia;
• ALT or AST is greater than 2.0×ULN; Serum Creatinine (SCr) is greater than 1.5×ULN or Creatinine Clearance (CrCl) is less than 50 ml/min;
• Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
• Thrombectomy or interventional therapy has been applied or planned after this onset;
• Patients with malignant tumors or receiving concurrent antitumor treatment;
• Patients with severe systemic disease, life expectancy is less than 90 days;
• Allergic to edaravone , taurine or related excipients;
• Pregnant or lactating women;
• Have major surgery within 4 weeks before enrollment and not recovered enough to start the study;
• Participated in other clinical studies within 30 days before randomization;
• The investigators consider the patients are not suitable for this trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 4 patient groups, including a placebo group

Compound Edaravone Injection-Low dose

Experimental group

Treatment:

Drug: Compound Edaravone Injection-Low dose

Compound Edaravone Injection-High dose

Experimental group

Treatment:

Drug: Compound Edaravone Injection-High dose

Edaravone Injection

Active Comparator group

Treatment:

Drug: Edaravone Injection

Placebo Injection

Placebo Comparator group

Treatment:

Drug: Placebo injection