ID

42963

Description

see http://clinicaltrials.gov/ct2/show/study/NCT00044915

Link

http://clinicaltrials.gov/ct2/show/study/NCT00044915

Keywords

Versions (3)
  1. 11/11/11 11/11/11 -
  2. 3/22/14 3/22/14 - Martin Dugas
  3. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Criteria NCT00044915

German English

Eligibility NCT00044915

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility NCT00044915
Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI
C1512693
Acute ischemic stroke of hemispheric localization (exclude brainstem and cerebellum), of suspected thromboembolic origin
Description

Acute ischemic stroke

Data type

boolean

Alias
UMLS CUI-1
C0038454
Males or females aged 18 years or over
Description

Age

Data type

boolean

Alias
UMLS CUI-1
C0001779
National Institute of Health Stroke Scale (NIH-SS) total score 8 to 23 with a motor deficit >/= 2 (for either one arm or leg) and level of consciousness < 2 and at least one of the following: Visual field deficit, neglect, or aphasia. If a patient receives t-PA, NIH-SS must be performed prior to receiving the study drug but after infusion of t-PA is initiated
Description

NIH-SS

Data type

boolean

Alias
UMLS CUI-1
C1697238
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI
C0680251
CT scan evidence of clearly defined areas of hypodensity indicating infarction of >1/3 of the MCA territory or evidence of significant mass effect with shift of midline or major areas of sulcal effacement associated with loss of cortical definition (grey-white distinction). Minor early CT changes are common in MCA strokes and patients with early or subtle changes are eligible.
Description

CT hypodensity

Data type

boolean

Alias
UMLS CUI-1
C0040405
UMLS CUI-2
CL381576
CT scan evidence of a primary intra-cerebral haemorrhage or any finding not consistent with an acute ischemic stroke as the cause of presenting symptoms
Description

CT intra-cerebral haemorrhage

Data type

boolean

Alias
UMLS CUI-1
C0040405
UMLS CUI-2
C0472369
Clinical evidence of acute stroke due to lacunar infarct (pure motor hemiplegia; pure sensory deficit, ataxia/clumsy hand syndromes)
Description

Lacunar infarct

Data type

boolean

Alias
UMLS CUI-1
C0333559
Neurological (other than the presenting stroke) or psychiatric conditions that may affect the patient's functional status and/or that may interfere with the patient's assessment
Description

Neurologic or Psychiatric

Data type

boolean

Alias
UMLS CUI-1
C0027765
UMLS CUI-2
C0233401
Clinically relevant pre-existing neurological deficit (Historical Rankin score >/= 2 regardless of cause)
Description

Pre-existing neurological deficit

Data type

boolean

Alias
UMLS CUI-1
CL423500
Generalized seizures having developed since the onset of stroke symptoms
Description

Generalized seizures

Data type

boolean

Alias
UMLS CUI-1
C0234533
Systolic blood pressure >210 or <110 mmHg (confirmed by up to three readings prior to randomization)
Description

Systolic blood pressure

Data type

boolean

Alias
UMLS CUI-1
C0871470
Diastolic blood pressure >110 or <60 mmHg (confirmed by up to three readings prior to randomization)
Description

Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI-1
C0428883
Myocardial infarction within 3 months, unstable angina within 3-5 days prior to starting infusion, unstable supra-ventricular and/or ventricular arrhythmia, severe conduction defect (AV block grades 2 and 3), complete left or right Bundle Branch Block, bradycardia (heart rate [HR] less than 50 bpm), uncompensated heart failure
Description

Myocardial infarction or arrhythmia

Data type

boolean

Alias
UMLS CUI-1
C0027051
UMLS CUI-2
C0003811
History of myocarditis, cardiomyopathy or aortic stenosis
Description

Myocarditis, cardiomyopathy, aortic stenosis

Data type

boolean

Alias
UMLS CUI-1
C0027059
Patients known to have prolonged QTc intervals (inherited and sporadic syndromes of QTc prolongation or QTc interval >450 msec males and 470 msec females on baseline ECG) or using Class IA or Class III antiarrhythmic drugs (e.g., quinidine, procainamide, amiodarone, sotalol)
Description

Prolonged Qtc

Data type

boolean

Alias
UMLS CUI-1
C0151878
Any patients that require initiation of new digoxin therapy are excluded. Patients already on digoxin therapy (for at least 1 month stable dose) at time of enrollment will be allowed in the study.
Description

Digoxin

Data type

boolean

Alias
UMLS CUI-1
CL425202
Electrolyte imbalance at baseline. Should the results not be available before starting the study drug infusion, the patients will be allowed in the study providing that the corrective therapy of any abnormal electrolyte results is implemented immediately upon availability of the laboratory report.
Description

Electrolyte imbalance

Data type

boolean

Alias
UMLS CUI-1
CL354536
Any conditions predisposing to electrolyte imbalances (e.g., chronic vomiting, anorexia nervosa, bulimia nervosa) will also be excluded at baseline.
Description

Electrolyte imbalance

Data type

boolean

Alias
UMLS CUI-1
CL354536
UMLS CUI-2
C0743223
Participation in a research protocol for investigation of a pharmaceutical agent or innovative invasive procedure (including intra-arterial t-PA) within the past 30 days
Description

Subject Participation Status in Clinical Study

Data type

boolean

Alias
UMLS CUI-1
C2348568
Previously in the BRAIN-Study or treated with repinotan
Description

Previously in BRAIN-Study

Data type

boolean

Alias
UMLS CUI-1
C2348568
Life expectancy of less than 6 months due to comorbid conditions
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI-1
C0023671
Any other known clinically significant medical disorder (e.g., cardiovascular, gastrointestinal, hepatic, renal, endocrine, major uncompensated metabolic disturbances, respiratory, immunological, hematological or bleeding disorder, cancer, AIDS)
Description

Significant medical disorder

Data type

boolean

Alias
UMLS CUI-1
CL437144
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Similar models

Eligibility NCT00044915

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility NCT00044915
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
C1512693 (UMLS CUI)
Acute ischemic stroke
Item
Acute ischemic stroke of hemispheric localization (exclude brainstem and cerebellum), of suspected thromboembolic origin
boolean
C0038454 (UMLS CUI-1)
Age
Item
Males or females aged 18 years or over
boolean
C0001779 (UMLS CUI-1)
NIH-SS
Item
National Institute of Health Stroke Scale (NIH-SS) total score 8 to 23 with a motor deficit >/= 2 (for either one arm or leg) and level of consciousness < 2 and at least one of the following: Visual field deficit, neglect, or aphasia. If a patient receives t-PA, NIH-SS must be performed prior to receiving the study drug but after infusion of t-PA is initiated
boolean
C1697238 (UMLS CUI-1)
Item Group
Exclusion criteria
C0680251 (UMLS CUI)
CT hypodensity
Item
CT scan evidence of clearly defined areas of hypodensity indicating infarction of >1/3 of the MCA territory or evidence of significant mass effect with shift of midline or major areas of sulcal effacement associated with loss of cortical definition (grey-white distinction). Minor early CT changes are common in MCA strokes and patients with early or subtle changes are eligible.
boolean
C0040405 (UMLS CUI-1)
CL381576 (UMLS CUI-2)
CT intra-cerebral haemorrhage
Item
CT scan evidence of a primary intra-cerebral haemorrhage or any finding not consistent with an acute ischemic stroke as the cause of presenting symptoms
boolean
C0040405 (UMLS CUI-1)
C0472369 (UMLS CUI-2)
Lacunar infarct
Item
Clinical evidence of acute stroke due to lacunar infarct (pure motor hemiplegia; pure sensory deficit, ataxia/clumsy hand syndromes)
boolean
C0333559 (UMLS CUI-1)
Neurologic or Psychiatric
Item
Neurological (other than the presenting stroke) or psychiatric conditions that may affect the patient's functional status and/or that may interfere with the patient's assessment
boolean
C0027765 (UMLS CUI-1)
C0233401 (UMLS CUI-2)
Pre-existing neurological deficit
Item
Clinically relevant pre-existing neurological deficit (Historical Rankin score >/= 2 regardless of cause)
boolean
CL423500 (UMLS CUI-1)
Generalized seizures
Item
Generalized seizures having developed since the onset of stroke symptoms
boolean
C0234533 (UMLS CUI-1)
Systolic blood pressure
Item
Systolic blood pressure >210 or <110 mmHg (confirmed by up to three readings prior to randomization)
boolean
C0871470 (UMLS CUI-1)
Diastolic blood pressure
Item
Diastolic blood pressure >110 or <60 mmHg (confirmed by up to three readings prior to randomization)
boolean
C0428883 (UMLS CUI-1)
Myocardial infarction or arrhythmia
Item
Myocardial infarction within 3 months, unstable angina within 3-5 days prior to starting infusion, unstable supra-ventricular and/or ventricular arrhythmia, severe conduction defect (AV block grades 2 and 3), complete left or right Bundle Branch Block, bradycardia (heart rate [HR] less than 50 bpm), uncompensated heart failure
boolean
C0027051 (UMLS CUI-1)
C0003811 (UMLS CUI-2)
Myocarditis, cardiomyopathy, aortic stenosis
Item
History of myocarditis, cardiomyopathy or aortic stenosis
boolean
C0027059 (UMLS CUI-1)
Prolonged Qtc
Item
Patients known to have prolonged QTc intervals (inherited and sporadic syndromes of QTc prolongation or QTc interval >450 msec males and 470 msec females on baseline ECG) or using Class IA or Class III antiarrhythmic drugs (e.g., quinidine, procainamide, amiodarone, sotalol)
boolean
C0151878 (UMLS CUI-1)
Digoxin
Item
Any patients that require initiation of new digoxin therapy are excluded. Patients already on digoxin therapy (for at least 1 month stable dose) at time of enrollment will be allowed in the study.
boolean
CL425202 (UMLS CUI-1)
Electrolyte imbalance
Item
Electrolyte imbalance at baseline. Should the results not be available before starting the study drug infusion, the patients will be allowed in the study providing that the corrective therapy of any abnormal electrolyte results is implemented immediately upon availability of the laboratory report.
boolean
CL354536 (UMLS CUI-1)
Electrolyte imbalance
Item
Any conditions predisposing to electrolyte imbalances (e.g., chronic vomiting, anorexia nervosa, bulimia nervosa) will also be excluded at baseline.
boolean
CL354536 (UMLS CUI-1)
C0743223 (UMLS CUI-2)
Subject Participation Status in Clinical Study
Item
Participation in a research protocol for investigation of a pharmaceutical agent or innovative invasive procedure (including intra-arterial t-PA) within the past 30 days
boolean
C2348568 (UMLS CUI-1)
Previously in BRAIN-Study
Item
Previously in the BRAIN-Study or treated with repinotan
boolean
C2348568 (UMLS CUI-1)
Life expectancy
Item
Life expectancy of less than 6 months due to comorbid conditions
boolean
C0023671 (UMLS CUI-1)
Significant medical disorder
Item
Any other known clinically significant medical disorder (e.g., cardiovascular, gastrointestinal, hepatic, renal, endocrine, major uncompensated metabolic disturbances, respiratory, immunological, hematological or bleeding disorder, cancer, AIDS)
boolean
CL437144 (UMLS CUI-1)
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