ID
52
Beschrijving
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)
Trefwoorden
Versies (3)
- 11-11-11 11-11-11 -
- 22-03-14 22-03-14 - Martin Dugas
- 17-09-21 17-09-21 -
Geüploaded op
11 november 2011
DOI
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Licentie
Creative Commons BY-NC 3.0 Legacy
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Eligibility Criteria NCT00044915
Eligibility
- StudyEvent: Eligibility
Beschrijving
Exclusion criteria
Beschrijving
CT hypodensity
Datatype
boolean
Beschrijving
CT intra-cerebral haemorrhage
Datatype
boolean
Beschrijving
Lacunar infarct
Datatype
boolean
Beschrijving
Neurologic or psychiatric conditions
Datatype
boolean
Beschrijving
Pre-existing neurological deficit
Datatype
boolean
Beschrijving
Generalized seizures
Datatype
boolean
Beschrijving
Systolic blood pressure
Datatype
boolean
Beschrijving
Diastolic blood pressure
Datatype
boolean
Beschrijving
Myocardial infarction and arrhythmia
Datatype
boolean
Beschrijving
Myocarditis, cardiomyopathy, aortic stenosis
Datatype
boolean
Beschrijving
Qtc
Datatype
boolean
Beschrijving
Digoxin
Datatype
boolean
Beschrijving
Electrolyte imbalance
Datatype
boolean
Beschrijving
Electrolyte imbalance predisposition
Datatype
boolean
Beschrijving
Other protocols
Datatype
boolean
Beschrijving
Previously in BRAIN-Study
Datatype
boolean
Beschrijving
Life expectancy less than 6 months
Datatype
boolean
Beschrijving
Significant medical disorder
Datatype
boolean
Beschrijving
Medical Concepts
Beschrijving
Diagnosis
Datatype
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
Beschrijving
Stroke
Datatype
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
Beschrijving
Age
Datatype
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Beschrijving
NIH-SS
Datatype
string
Alias
- UMLS CUI
- C1697238
- MedDRA 13.1
- 10065527
Beschrijving
Pharmaceutical Preparations
Datatype
string
Alias
- UMLS CUI
- C0013227
Beschrijving
Diagnostic procedure
Datatype
string
Alias
- UMLS CUI
- C0430022
- SNOMED CT 2010_0731
- 103693007
- MedDRA 13.1
- 10061816
Beschrijving
CT scan
Datatype
string
Alias
- UMLS CUI
- C0040405
- MedDRA 13.1
- 10011603
Beschrijving
Ischemic stroke
Datatype
string
Alias
- UMLS CUI
- C0948008
- SNOMED CT 2010_0731
- 422504002
- MedDRA 13.1
- 10055221
Beschrijving
Hemorrhagic cerebral infarction
Datatype
string
Alias
- UMLS CUI
- C0472369
- SNOMED CT 2010_0731
- 230706003
- MedDRA 13.1
- 10019005
Beschrijving
Lacunar infarction
Datatype
string
Alias
- UMLS CUI
- C0333559
- SNOMED CT 2010_0731
- 81037000
- MedDRA 13.1
- 10051078
Beschrijving
Compliance
Datatype
string
Alias
- UMLS CUI
- C1321605
- SNOMED CT 2010_0731
- 405078008
Beschrijving
Rankin score
Datatype
string
Alias
- UMLS CUI
- CL423500
Beschrijving
Convulsions generalised
Datatype
string
Alias
- UMLS CUI
- C0234533
- SNOMED CT 2010_0731
- 246545002
- MedDRA 13.1
- 10010916
Beschrijving
Arterial blood pressure
Datatype
string
Alias
- UMLS CUI
- C1272641
- SNOMED CT 2010_0731
- 386534000
Beschrijving
CHD
Datatype
string
Alias
- UMLS CUI
- C0010068
- SNOMED CT 2010_0731
- 53741008
- MedDRA 13.1
- 10068617
- ICD-10 Version 2009
- I25.1
Beschrijving
Cardiac Arrhythmia
Datatype
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
Beschrijving
Heart failure
Datatype
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
Beschrijving
Cardiac disease
Datatype
string
Alias
- UMLS CUI
- C0018799
- SNOMED CT 2010_0731
- 56265001
- MedDRA 13.1
- 10061024
Beschrijving
Prolonged QTc interval
Datatype
string
Alias
- UMLS CUI
- C1560305
Beschrijving
Antiarrhythmic drug
Datatype
string
Alias
- UMLS CUI
- C0003195
- SNOMED CT 2010_0731
- 67507000
Beschrijving
Potassium
Datatype
string
Alias
- UMLS CUI
- C0202194
- SNOMED CT 2010_0731
- 88480006
- LOINC
- 2823-3
- MedDRA 13.1
- 10036439
Beschrijving
Sodium
Datatype
string
Alias
- UMLS CUI
- C0037473
- SNOMED CT 2010_0731
- 39972003
- LOINC
- 2951-2
- MedDRA 13.1
- 10041263
Beschrijving
Enrollment
Datatype
string
Alias
- UMLS CUI
- C1516879
Beschrijving
Life expectancy
Datatype
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)