Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

NCT ID: NCT04984577

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Compound Edaravone Injection-Low dose

Group Type: EXPERIMENTAL

Compound Edaravone Injection-Low dose

Intervention Type: DRUG

Compound Edaravone Injection 30mg/dose (Edaravone 30mg, Taurine 600 mg), one dose every 12 hours, continue for 14 days

Compound Edaravone Injection-High dose

Group Type: EXPERIMENTAL

Compound Edaravone Injection-High dose

Intervention Type: DRUG

Compound Edaravone Injection 50mg/dose (Edaravone 50mg, Taurine 1000 mg), one dose every 12 hours, continue for 14 days

Edaravone Injection

Group Type: ACTIVE_COMPARATOR

Edaravone Injection

Intervention Type: DRUG

Edaravone Injection 30mg/dose, one dose every 12 hours, continue for 14 days

Placebo Injection

Group Type: PLACEBO_COMPARATOR

Placebo injection

Intervention Type: DRUG

Placebo injection, one dose every 12 hours, continue for 14 days

Interventions

Compound Edaravone Injection-Low dose

Compound Edaravone Injection 30mg/dose (Edaravone 30mg, Taurine 600 mg), one dose every 12 hours, continue for 14 days

Intervention Type: DRUG

Compound Edaravone Injection-High dose

Compound Edaravone Injection 50mg/dose (Edaravone 50mg, Taurine 1000 mg), one dose every 12 hours, continue for 14 days

Intervention Type: DRUG

Edaravone Injection

Edaravone Injection 30mg/dose, one dose every 12 hours, continue for 14 days

Intervention Type: DRUG

Placebo injection

Placebo injection, one dose every 12 hours, continue for 14 days

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Yoko Biomedical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tiantan Hospital，Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

NJYK-CPEDRV-II

Identifier Type: -

Identifier Source: org_study_id