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Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02430350
First received: April 20, 2015
Last updated: January 12, 2017
Last verified: January 2017
History of Changes
April 20, 2015
January 12, 2017
May 2015
December 2016   (Final data collection date for primary outcome measure)
The proportion of patients with mRS ≤1 on day 90 [ Time Frame: day 90 ]
Same as current
Complete list of historical versions of study NCT02430350 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke
Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Parallel, and Active-controlled PhaseⅢTrial
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Ischemic Stroke
  • Drug: Compound Edaravone Injection
  • Drug: Edaravone Injection
  • Experimental: Compound Edaravone
    Compound Edaravone Injection 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days
    Intervention: Drug: Compound Edaravone Injection
  • Active Comparator: Edaravone
    Edaravone Injection 30 mg/dose, one dose every 12 hours, continues for 14 days
    Intervention: Drug: Edaravone Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
December 2016
December 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
35 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT02430350
SIM-23-02
Yes
Not Provided
Plan to Share IPD: Undecided
Jiangsu Simcere Pharmaceutical Co., Ltd.
Jiangsu Simcere Pharmaceutical Co., Ltd.
Not Provided
Principal Investigator: Yongjun Wang, MD Beijing Tiantan Hospital
Jiangsu Simcere Pharmaceutical Co., Ltd.
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP