Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke - Full Text View

Purpose

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.

Condition	Intervention	Phase
Acute Ischemic Stroke	Drug: Compound Edaravone Injection Drug: Edaravone Injection	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Parallel, and Active-controlled PhaseⅢTrial

Resource links provided by NLM:

Drug Information available for: Edaravone

U.S. FDA Resources

Further study details as provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

The proportion of patients with mRS ≤1 on day 90 [ Time Frame: day 90 ]

Secondary Outcome Measures:

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


Enrollment:	1200
Study Start Date:	May 2015
Study Completion Date:	December 2016
Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Compound Edaravone Compound Edaravone Injection 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days	Drug: Compound Edaravone Injection
Active Comparator: Edaravone Edaravone Injection 30 mg/dose, one dose every 12 hours, continues for 14 days	Drug: Edaravone Injection

Eligibility


Ages Eligible for Study:	35 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02430350

Show 48 Study Locations

Sponsors and Collaborators

Jiangsu Simcere Pharmaceutical Co., Ltd.

Investigators


Principal Investigator:	Yongjun Wang, MD	Beijing Tiantan Hospital

More Information


Responsible Party:	Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT02430350 History of Changes
Other Study ID Numbers:	SIM-23-02
Study First Received:	April 20, 2015
Last Updated:	January 12, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:


Stroke Ischemia Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Phenylmethylpyrazolone	Antipyrine Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents

ClinicalTrials.gov processed this record on July 14, 2017