Description:

ODM derived from http://clinicaltrials.gov/show/NCT00190047

Link:

http://clinicaltrials.gov/show/NCT00190047

Keywords:
Versions (2) ▾
  1. 12/13/11
  2. 4/13/14
Uploaded on:

December 13, 2011

DOI:
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License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00190047 Stroke

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
18 Years to 85 Years
Patients with ischemic stroke, (that is, stroke that results from a blockage of blood flow to part of the brain), which is accompanied by language dysfunction (e.g. inability to understand speech), visual field defect or inattention to one side of the body or the space around the patient
Patients in whom the study treatment can start no less than 1 and not more than 9 hours after the stroke's onset
Patients with moderate-severe degree of neurological deficit in the 9 hours after stroke onset (defined as NIHSS score of 7 to 20)
Patients that can understand the requirements of the study and are willing to provide written informed consent (If the subject is incapacitated, informed consent will be sought from a legally acceptable representative.)
Exclusion Criteria
Patients with a brain (intracerebral or subarachnoid) hemorrhage per screening computed tomography scan
candidates for thrombolytic therapy for the current stroke
patients having a mental impairment that renders them incapable to understand the study's requirements
patients with other diseases that in the investigator's opinion may lead, independently of the current stroke, to further deterioration in the subject's neurological status during the trial period, or may confuse the evaluation of the present stroke
Patients likely to undergo a procedure involving cardiopulmonary bypass during the study period
Patients with medical conditions that may not enable them to complete the study (e.g life-threatening diseases,)
Patients whose condition improves already during the screening period
Patients who already have functional limitations before the present study (retrospective Modified Rankin Scale score of >3)
Patients who suffered a stroke within the past 90 days that seems to have been in the same brain region as the current acute stroke
Patients with severe hypertension (systolic BP >210 mm Hg or diastolic BP >120 mm Hg) or hypotension (systolic BP <90 mm Hg),
Patients with significant history of renal or liver disease(s) (serum creatinine of > 2.0 mg/dL, alanine aminotransferase, aspartate aminotransferase, or gamma-glutamyl transferase values of > threefold the upper normal limit)
Patients with a platelet count of <100,000/mm3
Female patients of childbearing potential who are not using adequate and effective birth control measures or who are pregnant or lactating (the screening evaluation of female subjects of childbearing potential will include a serum pregnancy test.)
Patients who are users of addictive agents, or alcoholics
Patients who have received an investigational drug within the 90 days before the present stroke or such that are past recipients of DP-b99
Medical concepts