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OpenTrials
Completed

NCT Number: NCT01929096

Compound Edaravone Injection for Acute Ischemic Stroke

1. To investigate the efficacy and safety of multi-doses Compound Edaravone Injection versus Edaravone Injection for acute ischemic stroke patients; 2. To provide evidence for the design of Compound Edaravone Injection Phase III trial.

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Key information

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Tiantan Hospital affiliated to Capital Medical University, Beijing, Beijing Municipality, China

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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 to 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;
  • Creatinine clearance is less than 30 ml/min or previously known severe renal diseases;
  • Therapeutic neuroprotective agents have been applied after onset, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;
  • Arterial or venous thrombolytic therapy has been applied after onset;
  • With malignant tumors or receiving concurrent antitumor treatment;
  • With severe systemic disease, life expectancy is less than 90 days;
  • Pregnant or lactating women;
  • Participate in other clinical studies within 30 days before randomization;
  • 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. mRS score on day 90

    Time frame: day 90

  2. Change from baseline NIHSS score on day 14

    Time frame: day 14

Secondary outcomes

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

    Time frame: day 14, 30, 90

  2. 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

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

    Time frame: day 14, 30, 90

  4. 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, Multi-dose, Parallel, and Controlled Phase II Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Aug 27, 2013
Registry last updated
Jul 3, 2015

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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