ID
52
Descripción
Repinotan in Patients With Acute Ischemic Stroke Inclusion Criteria: - Acute ischemic stroke of hemispheric localization (exclude brainstem and cerebellum), of suspected thromboembolic origin. - Males or females aged 18 years or over - 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. - Signed informed consent from patient or legally authorized representative Exclusion Criteria: - 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. -- A primary intra-cerebral haemorrhage or any finding not consistent with an acute ischemic stroke as the cause of presenting symptoms. - Clinical evidence of acute stroke due to lacunar infarct (pure motor hemiplegia; pure sensory deficit, ataxia/clumsy hand syndromes) - 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 - Clinically relevant pre-existing neurological deficit (Historical Rankin score >/= 2 regardless of cause) - Generalized seizures having developed since the onset of stroke symptoms - Systolic blood pressure >210 or <110 mmHg (confirmed by up to three readings prior to randomization) - Diastolic blood pressure >110 or <60 mmHg (confirmed by up to three readings prior to randomization) - 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 - History of myocarditis, cardiomyopathy or aortic stenosis - 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) - 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. - 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. - Any conditions predisposing to electrolyte imbalances (e.g., chronic vomiting, anorexia nervosa, bulimia nervosa) will also be excluded at baseline. - 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 - Previously in the BRAIN-Study or treated with repinotan - Life expectancy of less than 6 months due to comorbid conditions - 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)
Palabras clave
Versiones (3)
- 11/11/11 11/11/11 -
- 22/3/14 22/3/14 - Martin Dugas
- 17/9/21 17/9/21 -
Subido en
11 de noviembre de 2011
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0 Legacy
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Eligibility Criteria NCT00044915
Eligibility
- StudyEvent: Eligibility
Descripción
Exclusion criteria
Descripción
CT hypodensity
Tipo de datos
boolean
Descripción
CT intra-cerebral haemorrhage
Tipo de datos
boolean
Descripción
Lacunar infarct
Tipo de datos
boolean
Descripción
Neurologic or psychiatric conditions
Tipo de datos
boolean
Descripción
Pre-existing neurological deficit
Tipo de datos
boolean
Descripción
Generalized seizures
Tipo de datos
boolean
Descripción
Systolic blood pressure
Tipo de datos
boolean
Descripción
Diastolic blood pressure
Tipo de datos
boolean
Descripción
Myocardial infarction and arrhythmia
Tipo de datos
boolean
Descripción
Myocarditis, cardiomyopathy, aortic stenosis
Tipo de datos
boolean
Descripción
Qtc
Tipo de datos
boolean
Descripción
Digoxin
Tipo de datos
boolean
Descripción
Electrolyte imbalance
Tipo de datos
boolean
Descripción
Electrolyte imbalance predisposition
Tipo de datos
boolean
Descripción
Other protocols
Tipo de datos
boolean
Descripción
Previously in BRAIN-Study
Tipo de datos
boolean
Descripción
Life expectancy less than 6 months
Tipo de datos
boolean
Descripción
Significant medical disorder
Tipo de datos
boolean
Descripción
Medizinische Konzepte
Descripción
Diagnosis
Tipo de datos
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
Descripción
Stroke
Tipo de datos
string
Alias
- UMLS CUI
- C0038454
- SNOMED CT 2010_0731
- 230690007
- MedDRA 13.1
- 10042244
- ICD-10-CM Version 2010
- I63.9
- CTCAE Version 4.03
- E12826
Descripción
Age
Tipo de datos
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Descripción
NIH-SS
Tipo de datos
string
Alias
- UMLS CUI
- C1697238
- MedDRA 13.1
- 10065527
Descripción
Pharmaceutical Preparations
Tipo de datos
string
Alias
- UMLS CUI
- C0013227
Descripción
Diagnostic procedure
Tipo de datos
string
Alias
- UMLS CUI
- C0430022
- SNOMED CT 2010_0731
- 103693007
- MedDRA 13.1
- 10061816
Descripción
CT scan
Tipo de datos
string
Alias
- UMLS CUI
- C0040405
- MedDRA 13.1
- 10011603
Descripción
Ischemic stroke
Tipo de datos
string
Alias
- UMLS CUI
- C0948008
- SNOMED CT 2010_0731
- 422504002
- MedDRA 13.1
- 10055221
Descripción
Hemorrhagic cerebral infarction
Tipo de datos
string
Alias
- UMLS CUI
- C0472369
- SNOMED CT 2010_0731
- 230706003
- MedDRA 13.1
- 10019005
Descripción
Lacunar infarction
Tipo de datos
string
Alias
- UMLS CUI
- C0333559
- SNOMED CT 2010_0731
- 81037000
- MedDRA 13.1
- 10051078
Descripción
Compliance
Tipo de datos
string
Alias
- UMLS CUI
- C1321605
- SNOMED CT 2010_0731
- 405078008
Descripción
Rankin score
Tipo de datos
string
Alias
- UMLS CUI
- CL423500
Descripción
Convulsions generalised
Tipo de datos
string
Alias
- UMLS CUI
- C0234533
- SNOMED CT 2010_0731
- 246545002
- MedDRA 13.1
- 10010916
Descripción
Arterial blood pressure
Tipo de datos
string
Alias
- UMLS CUI
- C1272641
- SNOMED CT 2010_0731
- 386534000
Descripción
CHD
Tipo de datos
string
Alias
- UMLS CUI
- C0010068
- SNOMED CT 2010_0731
- 53741008
- MedDRA 13.1
- 10068617
- ICD-10 Version 2009
- I25.1
Descripción
Cardiac Arrhythmia
Tipo de datos
string
Alias
- UMLS CUI
- C0003811
- SNOMED CT 2010_0731
- 44808001
- MedDRA 13.1
- 10003119
- ICD-10-CM Version 2010
- I49.9
- ICD-9-CM Version 2011
- 427.9
Descripción
Heart failure
Tipo de datos
string
Alias
- UMLS CUI
- C0018801
- SNOMED CT 2010_0731
- 155374007
- MedDRA 13.1
- 10019279
- ICD-10-CM Version 2010
- I50
- ICD-9-CM Version 2011
- 428
- CTCAE Version 4.03
- E10124
Descripción
Cardiac disease
Tipo de datos
string
Alias
- UMLS CUI
- C0018799
- SNOMED CT 2010_0731
- 56265001
- MedDRA 13.1
- 10061024
Descripción
Prolonged QTc interval
Tipo de datos
string
Alias
- UMLS CUI
- C1560305
Descripción
Antiarrhythmic drug
Tipo de datos
string
Alias
- UMLS CUI
- C0003195
- SNOMED CT 2010_0731
- 67507000
Descripción
Potassium
Tipo de datos
string
Alias
- UMLS CUI
- C0202194
- SNOMED CT 2010_0731
- 88480006
- LOINC
- 2823-3
- MedDRA 13.1
- 10036439
Descripción
Sodium
Tipo de datos
string
Alias
- UMLS CUI
- C0037473
- SNOMED CT 2010_0731
- 39972003
- LOINC
- 2951-2
- MedDRA 13.1
- 10041263
Descripción
Enrollment
Tipo de datos
string
Alias
- UMLS CUI
- C1516879
Descripción
Life expectancy
Tipo de datos
string
Alias
- UMLS CUI
- C0023671
- LOINC Version 232
- LP75025-4
Similar models
Eligibility
- StudyEvent: Eligibility
439401001 (SNOMED CT 2010_0731)
230690007 (SNOMED CT 2010_0731)
10042244 (MedDRA 13.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE Version 4.03)
102518004 (SNOMED CT 2010_0731)
10065527 (MedDRA 13.1)
103693007 (SNOMED CT 2010_0731)
10061816 (MedDRA 13.1)
10011603 (MedDRA 13.1)
422504002 (SNOMED CT 2010_0731)
10055221 (MedDRA 13.1)
230706003 (SNOMED CT 2010_0731)
10019005 (MedDRA 13.1)
81037000 (SNOMED CT 2010_0731)
10051078 (MedDRA 13.1)
405078008 (SNOMED CT 2010_0731)
246545002 (SNOMED CT 2010_0731)
10010916 (MedDRA 13.1)
386534000 (SNOMED CT 2010_0731)
53741008 (SNOMED CT 2010_0731)
10068617 (MedDRA 13.1)
I25.1 (ICD-10 Version 2009)
44808001 (SNOMED CT 2010_0731)
10003119 (MedDRA 13.1)
I49.9 (ICD-10-CM Version 2010)
427.9 (ICD-9-CM Version 2011)
155374007 (SNOMED CT 2010_0731)
10019279 (MedDRA 13.1)
I50 (ICD-10-CM Version 2010)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE Version 4.03)
56265001 (SNOMED CT 2010_0731)
10061024 (MedDRA 13.1)
67507000 (SNOMED CT 2010_0731)