ID

38484

Description

Aspirin Responsiveness in Women With Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01406990

Link

https://clinicaltrials.gov/show/NCT01406990

Keywords

Versions (1)
  1. 10/22/19 10/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 22, 2019

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License

Creative Commons BY 4.0
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Eligibility CAD NCT01406990

English

Eligibility CAD NCT01406990

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility CAD NCT01406990
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
able and willing to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
women at least 45 years old of any race
Description

Gender | Age | Racial group Any

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0034510
UMLS CUI [3,2]
C1552551
taking 81 mg aspirin daily, for at least one month
Description

Aspirin U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0456683
diagnosed with known or suspected cad with at least one of the following: angiographic evidence of at least one lesion > 50% stenosis, history of significant elevation of biomarker troponin or ck-mb, or history of ecg changes in at least 2 contiguous leads characterized by either new st depression > 0.1 mv or transient (<30 min) st elevation > 0.1 mv, coronary artery revascularization either by pci or cabg
Description

Coronary Artery Disease | Coronary Artery Disease Suspected | Lesion Quantity Stenosis Percentage | Angiography | Troponin increased | Creatine kinase MB increased | ECG changes Leads Quantity | ST depression New | ST elevation Transient | Coronary revascularisation PCI | Coronary revascularisation CABG

Data type

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C1261287
UMLS CUI [3,4]
C0439165
UMLS CUI [4]
C0002978
UMLS CUI [5]
C1141948
UMLS CUI [6]
C0861005
UMLS CUI [7,1]
C0855329
UMLS CUI [7,2]
C0181586
UMLS CUI [7,3]
C1265611
UMLS CUI [8,1]
C0520887
UMLS CUI [8,2]
C0205314
UMLS CUI [9,1]
C0520886
UMLS CUI [9,2]
C0205374
UMLS CUI [10,1]
C0877341
UMLS CUI [10,2]
C1532338
UMLS CUI [11,1]
C0877341
UMLS CUI [11,2]
C0010055
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
< 45 years or > 85 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
clinically unstable: hypotension defined as sustained systolic blood pressure of <90 mmhg due to cardiac failure with associated symptoms, unstable or severe pulmonary edema, decompensated congestive heart failure, acute mitral regurgitation, acute ventricular septal defect, acute cerebrovascular event or transient ischemic attack (tia) within the past six months, history of ventricular fibrillation and no implantable cardioverter defibrillator (icd), sustained supraventricular tachycardia > 30 seconds or associated with symptoms and no icd, untreated complete heart block or untreated high grade secondary heart block
Description

Unstable status Clinical | Hypotension | Systolic Pressure | Heart failure Associated with Symptoms | Pulmonary Edema Unstable | Pulmonary Edema Severe | CONGESTIVE HEART FAILURE DECOMPENSATED | Mitral Valve Insufficiency | Ventricular Septal Defects | Cerebrovascular accident | Transient Ischemic Attack | Ventricular Fibrillation | Implantable defibrillator Absent | Supraventricular tachycardia Duration | Supraventricular tachycardia Associated with Symptoms | Complete atrioventricular block Untreated | Heart Block Secondary Severe Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0443343
UMLS CUI [1,2]
C0205210
UMLS CUI [2]
C0020649
UMLS CUI [3]
C0871470
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C1457887
UMLS CUI [5,1]
C0034063
UMLS CUI [5,2]
C0443343
UMLS CUI [6,1]
C0034063
UMLS CUI [6,2]
C0205082
UMLS CUI [7]
C0742746
UMLS CUI [8]
C0026266
UMLS CUI [9]
C0018818
UMLS CUI [10]
C0038454
UMLS CUI [11]
C0007787
UMLS CUI [12]
C0042510
UMLS CUI [13,1]
C0162589
UMLS CUI [13,2]
C0332197
UMLS CUI [14,1]
C0039240
UMLS CUI [14,2]
C0449238
UMLS CUI [15,1]
C0039240
UMLS CUI [15,2]
C0332281
UMLS CUI [15,3]
C1457887
UMLS CUI [16,1]
C0151517
UMLS CUI [16,2]
C0332155
UMLS CUI [17,1]
C0018794
UMLS CUI [17,2]
C0175668
UMLS CUI [17,3]
C0205082
UMLS CUI [17,4]
C0332155
pregnant, planning to become pregnant, or breastfeeding
Description

Pregnancy | Pregnancy, Planned | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
alcohol abuse or illicit drug abuse
Description

Alcohol abuse | DRUG ABUSE ILLICIT

Data type

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0743253
allergy or intolerance to salicylates and/or excipients including a history of and/or active gi bleed
Description

Salicylate allergy | Intolerance to Salicylate | Hypersensitivity Salicylate Excipient | Intolerance to Salicylate Excipient | Gastrointestinal Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0570514
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0036075
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0036075
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0036075
UMLS CUI [4,3]
C0015237
UMLS CUI [5]
C0017181
use of nsaids within seven days or planned regular use during the study
Description

NSAIDs | NSAIDs Regular Planned

Data type

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0205272
UMLS CUI [2,3]
C1301732
taking hrt or oral contraceptives within the past 30 days or planned use during study
Description

Hormone replacement therapy | Contraceptives, Oral | Hormone replacement therapy Planned | Oral Contraceptives Planned

Data type

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2]
C0009905
UMLS CUI [3,1]
C0282402
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0009905
UMLS CUI [4,2]
C1301732
use of heparin, warfarin, adp inhibitors (clopidogrel, prasugrel, or ticlopidine), or glycoprotein iib/iia inhibitors within previous 96 hours or planned use during the study
Description

Heparin | Warfarin | Adenosine Diphosphate Receptor Inhibitors | clopidogrel | prasugrel | Ticlopidine | Platelet Glycoprotein IIb/IIIA Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0019134
UMLS CUI [2]
C0043031
UMLS CUI [3]
C1373149
UMLS CUI [4]
C0070166
UMLS CUI [5]
C1620287
UMLS CUI [6]
C0040207
UMLS CUI [7]
C1373125
use or planned use of any other medications known to interfere with aa-induced platelet function
Description

Pharmaceutical Preparations Interfere with Arachidonic acid induced platelet aggregation

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1268820
currently participating in another investigational drug or device study
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
survival less than six months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility CAD NCT01406990

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility CAD NCT01406990
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
able and willing to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Gender | Age | Racial group Any
Item
women at least 45 years old of any race
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0034510 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
Aspirin U/day
Item
taking 81 mg aspirin daily, for at least one month
boolean
C0004057 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Coronary Artery Disease | Coronary Artery Disease Suspected | Lesion Quantity Stenosis Percentage | Angiography | Troponin increased | Creatine kinase MB increased | ECG changes Leads Quantity | ST depression New | ST elevation Transient | Coronary revascularisation PCI | Coronary revascularisation CABG
Item
diagnosed with known or suspected cad with at least one of the following: angiographic evidence of at least one lesion > 50% stenosis, history of significant elevation of biomarker troponin or ck-mb, or history of ecg changes in at least 2 contiguous leads characterized by either new st depression > 0.1 mv or transient (<30 min) st elevation > 0.1 mv, coronary artery revascularization either by pci or cabg
boolean
C1956346 (UMLS CUI [1])
C1956346 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1261287 (UMLS CUI [3,3])
C0439165 (UMLS CUI [3,4])
C0002978 (UMLS CUI [4])
C1141948 (UMLS CUI [5])
C0861005 (UMLS CUI [6])
C0855329 (UMLS CUI [7,1])
C0181586 (UMLS CUI [7,2])
C1265611 (UMLS CUI [7,3])
C0520887 (UMLS CUI [8,1])
C0205314 (UMLS CUI [8,2])
C0520886 (UMLS CUI [9,1])
C0205374 (UMLS CUI [9,2])
C0877341 (UMLS CUI [10,1])
C1532338 (UMLS CUI [10,2])
C0877341 (UMLS CUI [11,1])
C0010055 (UMLS CUI [11,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
< 45 years or > 85 years of age
boolean
C0001779 (UMLS CUI [1])
Unstable status Clinical | Hypotension | Systolic Pressure | Heart failure Associated with Symptoms | Pulmonary Edema Unstable | Pulmonary Edema Severe | CONGESTIVE HEART FAILURE DECOMPENSATED | Mitral Valve Insufficiency | Ventricular Septal Defects | Cerebrovascular accident | Transient Ischemic Attack | Ventricular Fibrillation | Implantable defibrillator Absent | Supraventricular tachycardia Duration | Supraventricular tachycardia Associated with Symptoms | Complete atrioventricular block Untreated | Heart Block Secondary Severe Untreated
Item
clinically unstable: hypotension defined as sustained systolic blood pressure of <90 mmhg due to cardiac failure with associated symptoms, unstable or severe pulmonary edema, decompensated congestive heart failure, acute mitral regurgitation, acute ventricular septal defect, acute cerebrovascular event or transient ischemic attack (tia) within the past six months, history of ventricular fibrillation and no implantable cardioverter defibrillator (icd), sustained supraventricular tachycardia > 30 seconds or associated with symptoms and no icd, untreated complete heart block or untreated high grade secondary heart block
boolean
C0443343 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0020649 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C1457887 (UMLS CUI [4,3])
C0034063 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0034063 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0742746 (UMLS CUI [7])
C0026266 (UMLS CUI [8])
C0018818 (UMLS CUI [9])
C0038454 (UMLS CUI [10])
C0007787 (UMLS CUI [11])
C0042510 (UMLS CUI [12])
C0162589 (UMLS CUI [13,1])
C0332197 (UMLS CUI [13,2])
C0039240 (UMLS CUI [14,1])
C0449238 (UMLS CUI [14,2])
C0039240 (UMLS CUI [15,1])
C0332281 (UMLS CUI [15,2])
C1457887 (UMLS CUI [15,3])
C0151517 (UMLS CUI [16,1])
C0332155 (UMLS CUI [16,2])
C0018794 (UMLS CUI [17,1])
C0175668 (UMLS CUI [17,2])
C0205082 (UMLS CUI [17,3])
C0332155 (UMLS CUI [17,4])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
pregnant, planning to become pregnant, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Alcohol abuse | DRUG ABUSE ILLICIT
Item
alcohol abuse or illicit drug abuse
boolean
C0085762 (UMLS CUI [1])
C0743253 (UMLS CUI [2])
Salicylate allergy | Intolerance to Salicylate | Hypersensitivity Salicylate Excipient | Intolerance to Salicylate Excipient | Gastrointestinal Hemorrhage
Item
allergy or intolerance to salicylates and/or excipients including a history of and/or active gi bleed
boolean
C0570514 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0036075 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0036075 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C0036075 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0017181 (UMLS CUI [5])
NSAIDs | NSAIDs Regular Planned
Item
use of nsaids within seven days or planned regular use during the study
boolean
C0003211 (UMLS CUI [1])
C0003211 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Hormone replacement therapy | Contraceptives, Oral | Hormone replacement therapy Planned | Oral Contraceptives Planned
Item
taking hrt or oral contraceptives within the past 30 days or planned use during study
boolean
C0282402 (UMLS CUI [1])
C0009905 (UMLS CUI [2])
C0282402 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0009905 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Heparin | Warfarin | Adenosine Diphosphate Receptor Inhibitors | clopidogrel | prasugrel | Ticlopidine | Platelet Glycoprotein IIb/IIIA Inhibitors
Item
use of heparin, warfarin, adp inhibitors (clopidogrel, prasugrel, or ticlopidine), or glycoprotein iib/iia inhibitors within previous 96 hours or planned use during the study
boolean
C0019134 (UMLS CUI [1])
C0043031 (UMLS CUI [2])
C1373149 (UMLS CUI [3])
C0070166 (UMLS CUI [4])
C1620287 (UMLS CUI [5])
C0040207 (UMLS CUI [6])
C1373125 (UMLS CUI [7])
Pharmaceutical Preparations Interfere with Arachidonic acid induced platelet aggregation
Item
use or planned use of any other medications known to interfere with aa-induced platelet function
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1268820 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
currently participating in another investigational drug or device study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Life Expectancy
Item
survival less than six months
boolean
C0023671 (UMLS CUI [1])
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