ID

42831

Description

ODM derived from http://clinicaltrials.gov/show/NCT00501059

Link

http://clinicaltrials.gov/show/NCT00501059

Keywords

Versions (2)
  1. 12/10/13 12/10/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00501059 Moderate Risk of CVD

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 55
Description

age at least 55

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors:
Description

Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors:

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0035648
SNOMED CT 2011_0131
80943009
LOINC Version 232
MTHU028018
Elevated cholesterol (Tchol>200 mg/dL or LDL>130 mg/dL, as measured at screening) irrespective of current treatment
Description

Elevated cholesterol (Tchol>200 mg/dL or LDL>130 mg/dL, as measured at screening) irrespective of current treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0020443
SNOMED CT 2011_0131
13644009
MedDRA 14.1
10020603
CTCAE 1105E
E12127
UMLS CUI 2011AA
C0587184
SNOMED CT 2011_0131
270996006
MedDRA 14.1
10040188
UMLS CUI 2011AA
C0202117
SNOMED CT 2011_0131
113079009
MedDRA 14.1
10024900
UMLS CUI 2011AA
C0444706
SNOMED CT 2011_0131
258104002
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C2827774
Current smoking: defined as any cigarette smoking in the past 12 months
Description

Current smoking: defined as any cigarette smoking in the past 12 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0700219
Low HDL cholesterol (HDL<40 mg/dL, as measured at screening)
Description

Low HDL cholesterol (HDL<40 mg/dL, as measured at screening)

Data type

boolean

Alias
UMLS CUI 2011AA
C0151691
MedDRA 14.1
10020060
UMLS CUI 2011AA
C0444706
SNOMED CT 2011_0131
258104002
UMLS CUI 2011AA
C1409616
Elevated blood pressure (SBP>140 mmHg, as measured at screening)
Description

Elevated blood pressure (SBP>140 mmHg, as measured at screening)

Data type

boolean

Alias
UMLS CUI 2011AA
C0497247
SNOMED CT 2011_0131
24184005
MedDRA 14.1
10005750
UMLS CUI 2011AA
C1840374
UMLS CUI 2011AA
C0444706
SNOMED CT 2011_0131
258104002
UMLS CUI 2011AA
C1409616
Currently on any medication to treat high blood pressure
Description

Currently on any medication to treat high blood pressure

Data type

boolean

Alias
UMLS CUI 2011AA
C1553892
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0020538
SNOMED CT 2011_0131
38341003
MedDRA 14.1
10020772
LOINC Version 232
MTHU020789
ICD-10-CM Version 2010
I10
ICD-9-CM Version 2011
997.91
CTCAE 1105E
E13785
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)
Description

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)

Data type

boolean

Alias
UMLS CUI 2011AA
CL415097
UMLS CUI 2011AA
C0241889
SNOMED CT 2011_0131
57177007
UMLS CUI 2011AA
C1279919
SNOMED CT 2011_0131
264499004
UMLS CUI 2011AA
C0010068
SNOMED CT 2011_0131
53741008
MedDRA 14.1
10068617
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1517194
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Females aged 60 and above with 3 or more risk factors. Female Risk Factors:
Description

Females aged 60 and above with 3 or more risk factors. Female Risk Factors:

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0035648
SNOMED CT 2011_0131
80943009
LOINC Version 232
MTHU028018
Elevated cholesterol (Tchol>240 mg/dL or LDL>160 mg/dL, as measured at screening) irrespective of current treatment
Description

Elevated cholesterol (Tchol>240 mg/dL or LDL>160 mg/dL, as measured at screening) irrespective of current treatment

Data type

boolean

Alias
UMLS CUI 2011AA
C0020443
SNOMED CT 2011_0131
13644009
MedDRA 14.1
10020603
CTCAE 1105E
E12127
UMLS CUI 2011AA
C0587184
SNOMED CT 2011_0131
270996006
MedDRA 14.1
10040188
UMLS CUI 2011AA
C0202117
SNOMED CT 2011_0131
113079009
MedDRA 14.1
10024900
UMLS CUI 2011AA
C0444706
SNOMED CT 2011_0131
258104002
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C2827774
Current smoking: defined as any cigarette smoking in the past 12 months
Description

Current smoking: defined as any cigarette smoking in the past 12 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0700219
Low HDL cholesterol (HDL<40 mg/dL, as measured at screening)
Description

Low HDL cholesterol (HDL<40 mg/dL, as measured at screening)

Data type

boolean

Alias
UMLS CUI 2011AA
C0151691
MedDRA 14.1
10020060
UMLS CUI 2011AA
C0444706
SNOMED CT 2011_0131
258104002
UMLS CUI 2011AA
C1409616
Elevated blood pressure (SBP>140 mmHg, as measured at screening)
Description

Elevated blood pressure (SBP>140 mmHg, as measured at screening)

Data type

boolean

Alias
UMLS CUI 2011AA
C0497247
SNOMED CT 2011_0131
24184005
MedDRA 14.1
10005750
UMLS CUI 2011AA
C1840374
UMLS CUI 2011AA
C0444706
SNOMED CT 2011_0131
258104002
UMLS CUI 2011AA
C1409616
Currently on any medication to treat high blood pressure
Description

Currently on any medication to treat high blood pressure

Data type

boolean

Alias
UMLS CUI 2011AA
C1553892
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0020538
SNOMED CT 2011_0131
38341003
MedDRA 14.1
10020772
LOINC Version 232
MTHU020789
ICD-10-CM Version 2010
I10
ICD-9-CM Version 2011
997.91
CTCAE 1105E
E13785
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)
Description

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)

Data type

boolean

Alias
UMLS CUI 2011AA
CL415097
UMLS CUI 2011AA
C0241889
SNOMED CT 2011_0131
57177007
UMLS CUI 2011AA
C1279919
SNOMED CT 2011_0131
264499004
UMLS CUI 2011AA
C0010068
SNOMED CT 2011_0131
53741008
MedDRA 14.1
10068617
UMLS CUI 2011AA
C1517194
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial
Description

An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial

Data type

boolean

Alias
UMLS CUI 2011AA
C0162340
SNOMED CT 2011_0131
66216009
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0680734
UMLS CUI 2011AA
C1576874
UMLS CUI 2011AA
C0021430
UMLS CUI 2011AA
C2348568
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C1558950
CTCAE 1105E
MTHU112154
UMLS CUI 2011AA
C0027051
SNOMED CT 2011_0131
22298006
MedDRA 14.1
10028596
LOINC Version 232
MTHU035551
ICD-10-CM Version 2010
I21-I22
ICD-9-CM Version 2011
410
CTCAE 1105E
E10152
UMLS CUI 2011AA
C0038454
SNOMED CT 2011_0131
230690007
MedDRA 14.1
10042244
ICD-10-CM Version 2010
I63.9
CTCAE 1105E
E12826
UMLS CUI 2011AA
C0205042
SNOMED CT 2011_0131
41801008
LOINC Version 232
MTHU011042
UMLS CUI 2011AA
C0162577
SNOMED CT 2011_0131
418285008
MedDRA 14.1
10002475
LOINC Version 232
MTHU011020
UMLS CUI 2011AA
C0687568
UMLS CUI 2011AA
C0010055
SNOMED CT 2011_0131
232717009
MedDRA 14.1
10011077
ICD-9-CM Version 2011
36.10
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C0018802
SNOMED CT 2011_0131
42343007
MedDRA 14.1
10007559
LOINC Version 232
MTHU020787
ICD-10-CM Version 2010
I50.9
ICD-9-CM Version 2011
428.0
UMLS CUI 2011AA
C0411282
SNOMED CT 2011_0131
240918000
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
UMLS CUI 2011AA
C1317301
LOINC Version 232
MTHU015345
UMLS CUI 2011AA
C0035648
SNOMED CT 2011_0131
80943009
LOINC Version 232
MTHU028018
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid
Description

Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0004057
SNOMED CT 2011_0131
7947003
Recent (in the past year) history of gastrointestinal or genitourinary bleeding or other bleeding disorders
Description

Recent (in the past year) history of gastrointestinal or genitourinary bleeding or other bleeding disorders

Data type

boolean

Alias
UMLS CUI 2011AA
C0332185
SNOMED CT 2011_0131
6493001
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0017181
SNOMED CT 2011_0131
74474003
MedDRA 14.1
10017955
ICD-10-CM Version 2010
K92.2
ICD-9-CM Version 2011
578
UMLS CUI 2011AA
CL414651
UMLS CUI 2011AA
C0019080
SNOMED CT 2011_0131
50960005
MedDRA 14.1
10055798
ICD-10-CM Version 2010
R58
ICD-9-CM Version 2011
459.0
UMLS CUI 2011AA
C0398600
SNOMED CT 2011_0131
191280003
Active diagnosed and documented reflux esophagitis
Description

Active diagnosed and documented reflux esophagitis

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0677659
SNOMED CT 2011_0131
266433003
ICD-10-CM Version 2010
K21.0
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
Description

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

Data type

boolean

Alias
UMLS CUI 2011AA
C1699700
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C0740858
SNOMED CT 2011_0131
66214007
MedDRA 14.1
10066169
LOINC Version 232
MTHU019364
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1554962
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0679823
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Lactating women or women of childbearing potential
Description

Lactating women or women of childbearing potential

Data type

boolean

Alias
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
Severe liver disease or damage based on the clinical judgment of the investigator
Description

Severe liver disease or damage based on the clinical judgment of the investigator

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
UMLS CUI 2011AA
C0151763
SNOMED CT 2011_0131
243978007
MedDRA 14.1
10024668
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
Severe renal disease or damage based on the clinical judgement of the investigator
Description

Severe renal disease or damage based on the clinical judgement of the investigator

Data type

boolean

Alias
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or anticoagulant in the opinion of the physician
Description

A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or anticoagulant in the opinion of the physician

Data type

boolean

Alias
UMLS CUI 2011AA
CL335836
UMLS CUI 2011AA
C0004057
SNOMED CT 2011_0131
7947003
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0085826
SNOMED CT 2011_0131
372560006
UMLS CUI 2011AA
C0003280
SNOMED CT 2011_0131
372862008
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
C0031831
SNOMED CT 2011_0131
309343006
LOINC Version 232
MTHU010489
HL7 V3 2006_05
PHYS
A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDS
Description

A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDS

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0004096
SNOMED CT 2011_0131
195967001
MedDRA 14.1
10003553
LOINC Version 232
MTHU020815
ICD-10-CM Version 2010
J45
ICD-9-CM Version 2011
493
UMLS CUI 2011AA
C0205263
SNOMED CT 2011_0131
16404004
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
UMLS CUI 2011AA
C0036075
SNOMED CT 2011_0131
255637000
UMLS CUI 2011AA
C0003211
SNOMED CT 2011_0131
372665008
Chronic, frequent (> 5 days/month) use of NSAIDs (including aspirin, or aspirin containing products), COX-2 inhibitors or metamizole
Description

Chronic, frequent (> 5 days/month) use of NSAIDs (including aspirin, or aspirin containing products), COX-2 inhibitors or metamizole

Data type

boolean

Alias
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0332183
SNOMED CT 2011_0131
70232002
UMLS CUI 2011AA
C0003211
SNOMED CT 2011_0131
372665008
UMLS CUI 2011AA
C0004057
SNOMED CT 2011_0131
7947003
UMLS CUI 2011AA
C1257954
SNOMED CT 2011_0131
387050005
UMLS CUI 2011AA
C0012586
SNOMED CT 2011_0131
22165008
Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit
Description

Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit

Data type

boolean

Alias
UMLS CUI 2011AA
C2348568
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
anticoagulants, use, long term
Description

Current use of an anticoagulant medication

Data type

boolean

Alias
UMLS CUI 2011AA
C1388078
Sitting systolic blood pressure
Description

Sitting systolic blood pressure greater than 170 mmHg

Data type

boolean

Alias
UMLS CUI 2011AA
C1319893
SNOMED CT 2011_0131
407554009
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 55
Item
age at least 55
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
C0086582 (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
C0086287 (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
Exclusion Criteria
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)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Current use of an anticoagulant medication
Item
anticoagulants, use, long term
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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