Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 55
Item
Alter mindestens 55 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors:
Item
Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors:
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0035648 (UMLS CUI 2011AA)
80943009 (SNOMED CT 2011_0131)
MTHU028018 (LOINC Version 232)
Elevated cholesterol (Tchol>200 mg/dL or LDL>130 mg/dL, as measured at screening) irrespective of current treatment
Item
Elevated cholesterol (Tchol>200 mg/dL or LDL>130 mg/dL, as measured at screening) irrespective of current treatment
boolean
C0020443 (UMLS CUI 2011AA)
13644009 (SNOMED CT 2011_0131)
10020603 (MedDRA 14.1)
E12127 (CTCAE 1105E)
C0587184 (UMLS CUI 2011AA)
270996006 (SNOMED CT 2011_0131)
10040188 (MedDRA 14.1)
C0202117 (UMLS CUI 2011AA)
113079009 (SNOMED CT 2011_0131)
10024900 (MedDRA 14.1)
C0444706 (UMLS CUI 2011AA)
258104002 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C2827774 (UMLS CUI 2011AA)
Current smoking: defined as any cigarette smoking in the past 12 months
Item
Current smoking: defined as any cigarette smoking in the past 12 months
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0700219 (UMLS CUI 2011AA)
Low HDL cholesterol (HDL<40 mg/dL, as measured at screening)
Item
Low HDL cholesterol (HDL<40 mg/dL, as measured at screening)
boolean
C0151691 (UMLS CUI 2011AA)
10020060 (MedDRA 14.1)
C0444706 (UMLS CUI 2011AA)
258104002 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Elevated blood pressure (SBP>140 mmHg, as measured at screening)
Item
Elevated blood pressure (SBP>140 mmHg, as measured at screening)
boolean
C0497247 (UMLS CUI 2011AA)
24184005 (SNOMED CT 2011_0131)
10005750 (MedDRA 14.1)
C1840374 (UMLS CUI 2011AA)
C0444706 (UMLS CUI 2011AA)
258104002 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Currently on any medication to treat high blood pressure
Item
Currently on any medication to treat high blood pressure
boolean
C1553892 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0020538 (UMLS CUI 2011AA)
38341003 (SNOMED CT 2011_0131)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)
Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
Item
Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
boolean
CL415097 (UMLS CUI 2011AA)
C0241889 (UMLS CUI 2011AA)
57177007 (SNOMED CT 2011_0131)
C1279919 (UMLS CUI 2011AA)
264499004 (SNOMED CT 2011_0131)
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1517194 (UMLS CUI 2011AA)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Females aged 60 and above with 3 or more risk factors. Female Risk Factors:
Item
Females aged 60 and above with 3 or more risk factors. Female Risk Factors:
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0035648 (UMLS CUI 2011AA)
80943009 (SNOMED CT 2011_0131)
MTHU028018 (LOINC Version 232)
Elevated cholesterol (Tchol>240 mg/dL or LDL>160 mg/dL, as measured at screening) irrespective of current treatment
Item
Elevated cholesterol (Tchol>240 mg/dL or LDL>160 mg/dL, as measured at screening) irrespective of current treatment
boolean
C0020443 (UMLS CUI 2011AA)
13644009 (SNOMED CT 2011_0131)
10020603 (MedDRA 14.1)
E12127 (CTCAE 1105E)
C0587184 (UMLS CUI 2011AA)
270996006 (SNOMED CT 2011_0131)
10040188 (MedDRA 14.1)
C0202117 (UMLS CUI 2011AA)
113079009 (SNOMED CT 2011_0131)
10024900 (MedDRA 14.1)
C0444706 (UMLS CUI 2011AA)
258104002 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C2827774 (UMLS CUI 2011AA)
Current smoking: defined as any cigarette smoking in the past 12 months
Item
Current smoking: defined as any cigarette smoking in the past 12 months
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0700219 (UMLS CUI 2011AA)
Low HDL cholesterol (HDL<40 mg/dL, as measured at screening)
Item
Low HDL cholesterol (HDL<40 mg/dL, as measured at screening)
boolean
C0151691 (UMLS CUI 2011AA)
10020060 (MedDRA 14.1)
C0444706 (UMLS CUI 2011AA)
258104002 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Elevated blood pressure (SBP>140 mmHg, as measured at screening)
Item
Elevated blood pressure (SBP>140 mmHg, as measured at screening)
boolean
C0497247 (UMLS CUI 2011AA)
24184005 (SNOMED CT 2011_0131)
10005750 (MedDRA 14.1)
C1840374 (UMLS CUI 2011AA)
C0444706 (UMLS CUI 2011AA)
258104002 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Currently on any medication to treat high blood pressure
Item
Currently on any medication to treat high blood pressure
boolean
C1553892 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0020538 (UMLS CUI 2011AA)
38341003 (SNOMED CT 2011_0131)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)
Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
Item
Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
boolean
CL415097 (UMLS CUI 2011AA)
C0241889 (UMLS CUI 2011AA)
57177007 (SNOMED CT 2011_0131)
C1279919 (UMLS CUI 2011AA)
264499004 (SNOMED CT 2011_0131)
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
C1517194 (UMLS CUI 2011AA)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial
Item
An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial
boolean
C0162340 (UMLS CUI 2011AA)
66216009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0680734 (UMLS CUI 2011AA)
C1576874 (UMLS CUI 2011AA)
C0021430 (UMLS CUI 2011AA)
C2348568 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
History of a documented vascular event, such as MI, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant arrhythmias, or congestive heart failure or vascular intervention
Item
History of a documented vascular event, such as MI, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant arrhythmias, or congestive heart failure or vascular intervention
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C1558950 (UMLS CUI 2011AA)
MTHU112154 (CTCAE 1105E)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0205042 (UMLS CUI 2011AA)
41801008 (SNOMED CT 2011_0131)
MTHU011042 (LOINC Version 232)
C0162577 (UMLS CUI 2011AA)
418285008 (SNOMED CT 2011_0131)
10002475 (MedDRA 14.1)
MTHU011020 (LOINC Version 232)
C0687568 (UMLS CUI 2011AA)
C0010055 (UMLS CUI 2011AA)
232717009 (SNOMED CT 2011_0131)
10011077 (MedDRA 14.1)
36.10 (ICD-9-CM Version 2011)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C0411282 (UMLS CUI 2011AA)
240918000 (SNOMED CT 2011_0131)
Patients who are at higher than moderate risk on the basis of their diabetes status, other factors known to the investigator, or the currently used national risk score
Item
Patients who are at higher than moderate risk on the basis of their diabetes status, other factors known to the investigator, or the currently used national risk score
boolean
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C1317301 (UMLS CUI 2011AA)
MTHU015345 (LOINC Version 232)
C0035648 (UMLS CUI 2011AA)
80943009 (SNOMED CT 2011_0131)
MTHU028018 (LOINC Version 232)
CL102947 (UMLS CUI 2011AA)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid
Item
Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0004057 (UMLS CUI 2011AA)
7947003 (SNOMED CT 2011_0131)
Recent (in the past year) history of gastrointestinal or genitourinary bleeding or other bleeding disorders
Item
Recent (in the past year) history of gastrointestinal or genitourinary bleeding or other bleeding disorders
boolean
C0332185 (UMLS CUI 2011AA)
6493001 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0017181 (UMLS CUI 2011AA)
74474003 (SNOMED CT 2011_0131)
10017955 (MedDRA 14.1)
K92.2 (ICD-10-CM Version 2010)
578 (ICD-9-CM Version 2011)
CL414651 (UMLS CUI 2011AA)
C0019080 (UMLS CUI 2011AA)
50960005 (SNOMED CT 2011_0131)
10055798 (MedDRA 14.1)
R58 (ICD-10-CM Version 2010)
459.0 (ICD-9-CM Version 2011)
C0398600 (UMLS CUI 2011AA)
191280003 (SNOMED CT 2011_0131)
Active diagnosed and documented reflux esophagitis
Item
Active diagnosed and documented reflux esophagitis
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0677659 (UMLS CUI 2011AA)
266433003 (SNOMED CT 2011_0131)
K21.0 (ICD-10-CM Version 2010)
Patients presenting with any medical condition, or psychiatric or substance abuse disorder, that, in the opinion of the investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
Item
Patients presenting with any medical condition, or psychiatric or substance abuse disorder, that, in the opinion of the investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
boolean
C1699700 (UMLS CUI 2011AA)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0740858 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1554962 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Lactating women or women of childbearing potential
Item
Lactating women or women of childbearing potential
boolean
C2828358 (UMLS CUI 2011AA)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
Severe liver disease or damage based on the clinical judgment of the investigator
Item
Severe liver disease or damage based on the clinical judgment of the investigator
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0151763 (UMLS CUI 2011AA)
243978007 (SNOMED CT 2011_0131)
10024668 (MedDRA 14.1)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
Severe renal disease or damage based on the clinical judgement of the investigator
Item
Severe renal disease or damage based on the clinical judgement of the investigator
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or anticoagulant in the opinion of the physician
Item
A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or anticoagulant in the opinion of the physician
boolean
CL335836 (UMLS CUI 2011AA)
C0004057 (UMLS CUI 2011AA)
7947003 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0085826 (UMLS CUI 2011AA)
372560006 (SNOMED CT 2011_0131)
C0003280 (UMLS CUI 2011AA)
372862008 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDS
Item
A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDS
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0004096 (UMLS CUI 2011AA)
195967001 (SNOMED CT 2011_0131)
10003553 (MedDRA 14.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
C0205263 (UMLS CUI 2011AA)
16404004 (SNOMED CT 2011_0131)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0036075 (UMLS CUI 2011AA)
255637000 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
372665008 (SNOMED CT 2011_0131)
Chronic, frequent (> 5 days/month) use of NSAIDs (including aspirin, or aspirin containing products), COX-2 inhibitors or metamizole
Item
Chronic, frequent (> 5 days/month) use of NSAIDs (including aspirin, or aspirin containing products), COX-2 inhibitors or metamizole
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0332183 (UMLS CUI 2011AA)
70232002 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
372665008 (SNOMED CT 2011_0131)
C0004057 (UMLS CUI 2011AA)
7947003 (SNOMED CT 2011_0131)
C1257954 (UMLS CUI 2011AA)
387050005 (SNOMED CT 2011_0131)
C0012586 (UMLS CUI 2011AA)
22165008 (SNOMED CT 2011_0131)
Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit
Item
Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit
boolean
C2348568 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Current use of an anticoagulant medication
Item
Langzeitanwendung von Antikoagulanzien
boolean
C1388078 (UMLS CUI 2011AA)
Sitting systolic blood pressure greater than 170 mmHg
Item
Sitting systolic blood pressure
boolean
C1319893 (UMLS CUI 2011AA)
407554009 (SNOMED CT 2011_0131)

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