Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
50 Years and older
boolean
C0001779 (UMLS CUI-1)
Ischemic stroke
Item
Male or female subjects 55 year or older who have suffered an ischemic stroke within the past 90 days and who meet all other inclusion criteria. Include also patients of ages 50 - 54 years and/or 90 to 120 days after the qualifying stroke provided the patient has at least two of the following additional risk factors: Diabetes mellitus, Hypertension (systolic blood pressure (BP)>=140 millimeters of Mercury (mmHg) or diastolic BP>=90mmHg), Smoker at time of qualifying stroke, Obesity (Body mass index (BMI)>30, BMI=weight in kilograms (kg)/[height in meters (m)]2), Previous vascular disease (stroke, MI, or peripheral arterial disease prior to qualifying stroke), End-organ-damage (retinopathy, left ventricular hypertrophy (LVH), or microalbuminuria), Hyperlipidemia
boolean
C0948008 (UMLS CUI-1)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
hemorrhagic stroke
Item
hemorrhagic stroke (must be ruled out by imaging)
boolean
C0553692 (UMLS CUI-1)
unable to give informed consent
Item
unable to give informed consent
boolean
C1299582 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
other diseases
Item
known brain tumor, severe renal or hepatic insufficiency, current active peptic ulcer disease, severe coronary artery disease including unstable angina pectoris or an MI within the previous 3 months,or history of a hemostatic disorder or systemic bleeding
boolean
hyperkalemia
Item
hyperkalemia, uncorrected volume or sodium depletion
boolean
C0020461 (UMLS CUI-1)
pre-stroke history of dementia
Item
pre-stroke history of dementia, modified Rankin score greater than 4
boolean
qualifying stroke induced by surgical or cardiovascular procedure
Item
qualifying stroke induced by surgical or cardiovascular procedure
boolean
uncontrolled hypertension
Item
uncontrolled hypertension at entry above 180/110 mmHg (goal blood pressures are lower)
boolean
Blood pressure, ARB therapy, anticoagulation
Item
Systolic blood pressure (SBP) 120 mmHg or less for hospitalized patients. Currently taking an Angiotensin II receptor blocker (ARB) and not able or willing to switch to alternative. Required or planned continuing treatment with antithrombotics or anticoagulants including heparin or warfarin or non-study platelet inhibitors
boolean
syndrome of asthma, rhinitis and nasal polyps
Item
syndrome of asthma, rhinitis and nasal polyps
boolean
scheduled for major surgery
Item
scheduled for major surgery, carotid endarterectomy, or carotid angioplasty (4 weeks post surgery is allowed)
boolean
unlikely to be released from hospital
Item
unlikely to be released from hospital following the qualifying stroke or presence of a severe disability likely to lead to being bedridden or demented or a non-vascular disease or condition which makes it unlikely that the patient will survive to the end of the trial
boolean
history of thrombocytopenia or neutropenia
Item
history of thrombocytopenia or neutropenia
boolean
Item Group
Medical concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Ischemic stroke
Item
Ischemic stroke
string
C0948008 (UMLS CUI)
422504002 (SNOMED CT 2010_0731)
10055221 (MedDRA 13.1)
Diabetes mellitus
Item
Diabetes mellitus
string
C0011849 (UMLS CUI)
191044006 (SNOMED CT 2010_0731)
Hypertension
Item
Hypertensive disease
string
C0020538 (UMLS CUI)
38341003 (SNOMED CT 2010_0731)
10020772 (MedDRA 13.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE Version 4.03)
Smoking Status
Item
Smoking Status
text
C1519386 (UMLS CUI-1)
Obesity
Item
Obesity
string
C0028754 (UMLS CUI)
414916001 (SNOMED CT 2010_0731)
10029883 (MedDRA 13.1)
E66.0 (ICD-10-CM Version 2010)
278.00 (ICD-9-CM Version 2011)
E12361 (CTCAE Version 4.03)
BMI
Item
Body mass index
string
C1305855 (UMLS CUI)
140075008 (SNOMED CT 2010_0731)
10005894 (MedDRA 13.1)
LP35925-4 (LOINC Version 232)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Stroke
Item
Stroke
string
C0038454 (UMLS CUI)
230690007 (SNOMED CT 2010_0731)
10042244 (MedDRA 13.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE Version 4.03)
Acute myocardial infarction
Item
Acute myocardial infarction
string
C0155626 (UMLS CUI)
57054005 (SNOMED CT 2010_0731)
10000891 (MedDRA 13.1)
I21 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
PAD
Item
Peripheral Arterial Diseases
string
C1704436 (UMLS CUI)
399957001 (SNOMED CT 2010_0731)
10067825 (MedDRA 13.1)
Retinopathy
Item
Retinopathy
string
C0035309 (UMLS CUI)
399625000 (SNOMED CT 2010_0731)
10038923 (MedDRA 13.1)
E10432 (CTCAE Version 4.03)
LVH
Item
Left Ventricular Hypertrophy
string
C0149721 (UMLS CUI)
55827005 (SNOMED CT 2010_0731)
10049773 (MedDRA 13.1)
Microalbuminuria
Item
Microalbuminuria
string
C0730345 (UMLS CUI)
312975006 (SNOMED CT 2010_0731)
10027525 (MedDRA 13.1)
Hyperlipidaemia
Item
Hyperlipidemia
string
C0020473 (UMLS CUI)
55822004 (SNOMED CT 2010_0731)
10062060 (MedDRA 13.1)
E78.5 (ICD-10-CM Version 2010)
Haemorrhagic stroke
Item
Brain hemorrhage
string
C0553692 (UMLS CUI)
230706003 (SNOMED CT 2010_0731)
10019016 (MedDRA 13.1)
Brain tumor
Item
Brain Neoplasms
string
C0006118 (UMLS CUI)
126952004 (SNOMED CT 2010_0731)
10061019 (MedDRA 13.1)
239.6 (ICD-9-CM Version 2011)
Kidney Insufficiency
Item
Renal Insufficiency
string
C1565489 (UMLS CUI)
10038474 (MedDRA 13.1)
Liver Insufficiency
Item
Hepatic Insufficiency
string
C1306571 (UMLS CUI)
59927004 (SNOMED CT 2010_0731)
10056542 (MedDRA 13.1)
Gastroduodenal ulcer
Item
Peptic Ulcer
string
C0030920 (UMLS CUI)
13200003 (SNOMED CT 2010_0731)
10034341 (MedDRA 13.1)
K27 (ICD-10-CM Version 2010)
533 (ICD-9-CM Version 2011)
Coronary Heart Disease (CHD)
Item
Coronary artery disease (CAD)
string
C0010068 (UMLS CUI)
53741008 (SNOMED CT 2010_0731)
10068617 (MedDRA 13.1)
Bleeding diathesis
Item
Bleeding tendency
string
C0005779 (UMLS CUI)
248250000 (SNOMED CT 2010_0731)
10005134 (MedDRA 13.1)
Hyperpotassemia
Item
hyperkalemia
string
C0020461 (UMLS CUI)
14140009 (SNOMED CT 2010_0731)
10020646 (MedDRA 13.1)
E87.5 (ICD-10-CM Version 2010)
276.7 (ICD-9-CM Version 2011)
E12282 (CTCAE Version 4.03)
Dementia
Item
Dementia
string
C0497327 (UMLS CUI)
52448006 (SNOMED CT 2010_0731)
10012267 (MedDRA 13.1)
F03 (ICD-10-CM Version 2010)
290 (ICD-9-CM Version 2011)
Rankin score
Item
Rankin score
string
CL423500 (UMLS CUI)
Complications of medical and surgical care
Item
Complication of surgical and medical care, unspecified
string
C0274310 (UMLS CUI)
T88.9, Y62-Y84 (ICD-10-CM Version 2010)
Systolic Pressure
Item
Systolic Blood Pressure
string
C0871470 (UMLS CUI)
271649006 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Angiotensin II Receptor Blocker (ARB)
Item
Angiotensin II receptor antagonist
string
C0521942 (UMLS CUI)
372913009 (SNOMED CT 2010_0731)
Anticoagulant therapy
Item
Anticoagulant treatment
string
C0150457 (UMLS CUI)
182764009 (SNOMED CT 2010_0731)
10053468 (MedDRA 13.1)
Antithrombotic Agents
Item
Antithrombic Drugs
string
C1704311 (UMLS CUI)
Heparin
Item
Heparin
string
C0019134 (UMLS CUI)
372877000 (SNOMED CT 2010_0731)
MTHU003766 (LOINC Version 232)
Warfarin
Item
Warfarin
string
C0043031 (UMLS CUI)
48603004 (SNOMED CT 2010_0731)
MTHU003212 (LOINC Version 232)
Therapeutic procedure
Item
Therapeutic procedure
string
C0087111 (UMLS CUI)
Bronchial Asthma
Item
Asthma
string
C0004096 (UMLS CUI)
195967001 (SNOMED CT 2010_0731)
10003553 (MedDRA 13.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
Life expectancy
Item
Life expectancy
string
C0023671 (UMLS CUI)
LP75025-4 (LOINC Version 232)
Platelet count
Item
Platelet count - finding
string
C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)
WBC
Item
White Blood Cells
string
C0023508 (UMLS CUI)
767002 (SNOMED CT 2010_0731)
6690-2 (LOINC Version 232)
Neutrophil count decreased
Item
Neutropenia
string
C0853697 (UMLS CUI)
10029366 (MedDRA 13.1)
E12198 (CTCAE Version 4.03)
Thrombopenia
Item
Thrombocytopenia
string
C0040034 (UMLS CUI)
302215000 (SNOMED CT 2010_0731)
10043554 (MedDRA 13.1)
D69.6 (ICD-10-CM Version 2010)
287.5 (ICD-9-CM Version 2011)
E12207 (CTCAE Version 4.03)
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