ID
52
Beschreibung
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)
Stichworte
Versionen (3)
- 11.11.11 11.11.11 -
- 22.03.14 22.03.14 - Martin Dugas
- 17.09.21 17.09.21 -
Hochgeladen am
11. November 2011
DOI
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Eligibility Criteria NCT00044915
Eligibility
- StudyEvent: Eligibility
Beschreibung
Exclusion criteria
Beschreibung
CT hypodensity
Datentyp
boolean
Beschreibung
CT intra-cerebral haemorrhage
Datentyp
boolean
Beschreibung
Lacunar infarct
Datentyp
boolean
Beschreibung
Neurologic or psychiatric conditions
Datentyp
boolean
Beschreibung
Pre-existing neurological deficit
Datentyp
boolean
Beschreibung
Generalized seizures
Datentyp
boolean
Beschreibung
Systolic blood pressure
Datentyp
boolean
Beschreibung
Diastolic blood pressure
Datentyp
boolean
Beschreibung
Myocardial infarction and arrhythmia
Datentyp
boolean
Beschreibung
Myocarditis, cardiomyopathy, aortic stenosis
Datentyp
boolean
Beschreibung
Qtc
Datentyp
boolean
Beschreibung
Digoxin
Datentyp
boolean
Beschreibung
Electrolyte imbalance
Datentyp
boolean
Beschreibung
Electrolyte imbalance predisposition
Datentyp
boolean
Beschreibung
Other protocols
Datentyp
boolean
Beschreibung
Previously in BRAIN-Study
Datentyp
boolean
Beschreibung
Life expectancy less than 6 months
Datentyp
boolean
Beschreibung
Significant medical disorder
Datentyp
boolean
Beschreibung
Medical Concepts
Beschreibung
Diagnosis
Datentyp
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
Beschreibung
Stroke
Datentyp
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
Beschreibung
Age
Datentyp
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Beschreibung
NIH-SS
Datentyp
string
Alias
- UMLS CUI
- C1697238
- MedDRA 13.1
- 10065527
Beschreibung
Pharmaceutical Preparations
Datentyp
string
Alias
- UMLS CUI
- C0013227
Beschreibung
Diagnostic procedure
Datentyp
string
Alias
- UMLS CUI
- C0430022
- SNOMED CT 2010_0731
- 103693007
- MedDRA 13.1
- 10061816
Beschreibung
CT scan
Datentyp
string
Alias
- UMLS CUI
- C0040405
- MedDRA 13.1
- 10011603
Beschreibung
Ischemic stroke
Datentyp
string
Alias
- UMLS CUI
- C0948008
- SNOMED CT 2010_0731
- 422504002
- MedDRA 13.1
- 10055221
Beschreibung
Hemorrhagic cerebral infarction
Datentyp
string
Alias
- UMLS CUI
- C0472369
- SNOMED CT 2010_0731
- 230706003
- MedDRA 13.1
- 10019005
Beschreibung
Lacunar infarction
Datentyp
string
Alias
- UMLS CUI
- C0333559
- SNOMED CT 2010_0731
- 81037000
- MedDRA 13.1
- 10051078
Beschreibung
Compliance
Datentyp
string
Alias
- UMLS CUI
- C1321605
- SNOMED CT 2010_0731
- 405078008
Beschreibung
Rankin score
Datentyp
string
Alias
- UMLS CUI
- CL423500
Beschreibung
Convulsions generalised
Datentyp
string
Alias
- UMLS CUI
- C0234533
- SNOMED CT 2010_0731
- 246545002
- MedDRA 13.1
- 10010916
Beschreibung
Arterial blood pressure
Datentyp
string
Alias
- UMLS CUI
- C1272641
- SNOMED CT 2010_0731
- 386534000
Beschreibung
CHD
Datentyp
string
Alias
- UMLS CUI
- C0010068
- SNOMED CT 2010_0731
- 53741008
- MedDRA 13.1
- 10068617
- ICD-10 Version 2009
- I25.1
Beschreibung
Cardiac Arrhythmia
Datentyp
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
Beschreibung
Heart failure
Datentyp
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
Beschreibung
Cardiac disease
Datentyp
string
Alias
- UMLS CUI
- C0018799
- SNOMED CT 2010_0731
- 56265001
- MedDRA 13.1
- 10061024
Beschreibung
Prolonged QTc interval
Datentyp
string
Alias
- UMLS CUI
- C1560305
Beschreibung
Antiarrhythmic drug
Datentyp
string
Alias
- UMLS CUI
- C0003195
- SNOMED CT 2010_0731
- 67507000
Beschreibung
Potassium
Datentyp
string
Alias
- UMLS CUI
- C0202194
- SNOMED CT 2010_0731
- 88480006
- LOINC
- 2823-3
- MedDRA 13.1
- 10036439
Beschreibung
Sodium
Datentyp
string
Alias
- UMLS CUI
- C0037473
- SNOMED CT 2010_0731
- 39972003
- LOINC
- 2951-2
- MedDRA 13.1
- 10041263
Beschreibung
Enrollment
Datentyp
string
Alias
- UMLS CUI
- C1516879
Beschreibung
Life expectancy
Datentyp
string
Alias
- UMLS CUI
- C0023671
- LOINC Version 232
- LP75025-4
Ähnliche Modelle
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)