Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Phase 3

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Compound Edaravone Injection; Drug: Edaravone Injection

• Registration Number: NCT02430350
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-26
• Study First Posted: 2015-04-30
• Study Start: 2015-05
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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 or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis;
• Serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or previously known severe renal diseases;
• Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
• Arterial or venous thrombolytic therapy has been applied after onset of stroke;
• Patients with malignant tumors or receiving concurrent antitumor treatment;
• Patients with severe systemic disease, life expectancy is less than 90 days;
• allergic to edaravone , (+)-Borneol or related excipients;
• Pregnant or lactating women;
• Have major surgery within 4 weeks before enrollment;
• Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present;
• The investigators consider the patients are not suitable for this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compound Edaravone	Compound Edaravone Injection	Compound Edaravone Injection 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days
Edaravone	Edaravone Injection	Edaravone Injection 30 mg/dose, one dose every 12 hours, continues for 14 days

Primary Outcome Measures

Name	Time	Method
The proportion of patients with mRS ≤1 on day 90	day 90

Secondary Outcome Measures

Name	Time	Method
The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90	day 14, 30, 90
Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90	day 14, 30, 90
Stroke Impact Scale (SIS) score on day 90	day 90
Changes of NIHSS score from baseline on day 14	day 14
mRS score on day 90	day 90
The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90	day 14, 30, 90

Trial Locations

Locations (48)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Navy General Hospital of The Chinese PLA; 🇨🇳 Beijing, Beijing, China

Beijing Tian Tan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Jinan University; 🇨🇳 Guangzhou, Guangdong, China

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

Peking University Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China

Affiliated Hospital of Guilin Medical University; 🇨🇳 Guilin, Guangxi, China

Liuzhou Worker's Hospital; 🇨🇳 Liuzhou, Guangxi, China

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