Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

NCT ID: NCT02430350

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-12-31

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

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

Group Type: EXPERIMENTAL

Compound Edaravone Injection

Intervention Type: DRUG

Edaravone

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

Group Type: ACTIVE_COMPARATOR

Edaravone Injection

Intervention Type: DRUG

Interventions

Compound Edaravone Injection

Intervention Type: DRUG

Edaravone Injection

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 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yongjun Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Navy General Hospital of The Chinese PLA

Beijing, Beijing Municipality, China

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 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

Nanning Second People's Hospital

Nanning, Guangxi, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Cangzhou Central Hospital

Cangzhou, Hebei, China

The Second Affiliated Hospital of Haerbin Medical University

Haerbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, China

The Third Affiliated Hospital of Inner Mongolia Medical University

Baotou, Inner Mongolia, China

Central Hospital of Baotou

Baotou, Inner Mongolia, China

Inner Mongolia Autonomous Region People's Hospital

Hohhot, Inner Mongolia, China

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Huai'an First Affiliated Hospital of Nanjing Medical University

Huai'an, Jiangsu, China

Lianyungang First People's Hospital

Lianyungang, Jiangsu, China

Nanjing First Hospital

Nanjing, Jiangsu, China

Zhongda Hospital,Southeast University

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Nanjing Brain Hospital

Nanjing, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Yangzhou No.1 People's Hospital

Yangzhou, Jiangsu, China

The Second Hospital of Jilin University

Changchun, Jilin, China

The Forth Hospital of Jilin University

Siping, Jilin, China

Siping Central Hospital

Siping, Jilin, China

The General Hospital of Shenyang Military, Chinese PLA

Shenyang, Liaoning, China

The Sceond Hospital of Shandong University

Jinan, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Qingdao Municipal Hospital

Qingdao, Shandong, China

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Yangpu Hospital, Tongji University

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Lishui People's Hospital

Lishui, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Countries

China

References

Xu J, Wang A, Meng X, Yalkun G, Xu A, Gao Z, Chen H, Ji Y, Xu J, Geng D, Zhu R, Liu B, Dong A, Mu H, Lu Z, Li S, Zheng H, Chen X, Wang Y, Zhao X, Wang Y; TASTE Trial Investigatorsdagger. Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial. Stroke. 2021 Mar;52(3):772-780. doi: 10.1161/STROKEAHA.120.031197. Epub 2021 Feb 16.

Reference Type: DERIVED

PMID: 33588596 (View on PubMed)

Other Identifiers

SIM-23-02

Identifier Type: -

Identifier Source: org_study_id