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Completed

NCT Number: NCT02430350

Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Tian Tan Hospital, Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Compound Edaravone Injection

Drug

Edaravone Injection

Drug

Primary outcomes

  1. The proportion of patients with mRS ≤1 on day 90

    Time frame: day 90

Secondary outcomes

  1. mRS score on day 90

    Time frame: day 90

  2. Changes of NIHSS score from baseline on day 14

    Time frame: day 14

  3. The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90

    Time frame: day 14, 30, 90

  4. 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

  5. Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90

    Time frame: day 14, 30, 90

  6. Stroke Impact Scale (SIS) score on day 90

    Time frame: day 90

Sponsors and collaborators

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Parallel, and Active-controlled PhaseⅢTrial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 30, 2015
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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