ID

35581

Description

Comparison of TIcagrelor and Clopidogrel in Patients With Coronary Artery diseaSe and Type 2 Diabetes Mellitus (TICS-DM); ODM derived from: https://clinicaltrials.gov/show/NCT02457130

Link

https://clinicaltrials.gov/show/NCT02457130

Keywords

  1. 3/11/19 3/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 11, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Coronary Artery Disease NCT02457130

Eligibility Coronary Artery Disease NCT02457130

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of informed consent prior to any study specific procedures
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
age between 18 and 75 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
type 2 dm according to ada criteria
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
angiographically documented cad
Description

Coronary Artery Disease Angiography

Data type

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0002978
chronic treatment (>1 month) with aspirin (100mg/day)
Description

Aspirin chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0205191
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known allergies to aspirin, clopidogrel, or ticagrelor
Description

Aspirin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Ticagrelor

Data type

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0070166
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1999375
blood dyscrasia
Description

Hematological Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018939
any recent acute coronary syndrome (<30 days) or hemodinamic instability
Description

Acute Coronary Syndrome | Hemodynamic instability

Data type

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0948268
recent antiplatelet therapy (<14 days), with the exception of asa, including: thienopyridines, cilostazol, dipiridamol, glycoprotein iib/iiia inhibitors
Description

Antiplatelet therapy | Exception Aspirin | Thienopyridines | cilostazol | Dipyridamole | Platelet Glycoprotein IIb/IIIA Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C1096021
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004057
UMLS CUI [3]
C2936588
UMLS CUI [4]
C0055729
UMLS CUI [5]
C0012582
UMLS CUI [6]
C1373125
oral anticoagulation with a coumarin derivative
Description

Anticoagulation Therapy Oral | Coumarin Derivative

Data type

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0010206
UMLS CUI [2,2]
C1527240
concomitant treatment with a potent cyp3a4 inhibitor (e.g. ketoconazole, claritromicine, nefazodone, ritonavir, atazanavir)
Description

CYP3A4 Inhibitor | Ketoconazole | Clarithromycin | nefazodone | Ritonavir | Atazanavir

Data type

boolean

Alias
UMLS CUI [1]
C3830624
UMLS CUI [2]
C0022625
UMLS CUI [3]
C0055856
UMLS CUI [4]
C0068485
UMLS CUI [5]
C0292818
UMLS CUI [6]
C1145759
any active bleeding
Description

Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0019080
recent history of stroke, tia or intracranial bleeding (<6 months prior to inclusion)
Description

Cerebrovascular accident | Transient Ischemic Attack | Intracranial Hemorrhages

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
UMLS CUI [3]
C0151699
platelet count <100x106/microl
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
severe chronic kidney disease (creatinine clearance measured with cockcroft-gault formula <30ml/min)
Description

Chronic Kidney Disease Severe | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1,1]
C1561643
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C2711451
any active neoplasm
Description

Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0027651
baseline alt >2.5 times the upper limit of normality
Description

Alanine aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
pregnant or childbearing females
Description

Pregnancy | Childbirth

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C1148523

Similar models

Eligibility Coronary Artery Disease NCT02457130

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
provision of informed consent prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Age
Item
age between 18 and 75 years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 dm according to ada criteria
boolean
C0011860 (UMLS CUI [1])
Coronary Artery Disease Angiography
Item
angiographically documented cad
boolean
C1956346 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Aspirin chronic
Item
chronic treatment (>1 month) with aspirin (100mg/day)
boolean
C0004057 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Aspirin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Ticagrelor
Item
known allergies to aspirin, clopidogrel, or ticagrelor
boolean
C0004058 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0070166 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1999375 (UMLS CUI [3,2])
Hematological Disease
Item
blood dyscrasia
boolean
C0018939 (UMLS CUI [1])
Acute Coronary Syndrome | Hemodynamic instability
Item
any recent acute coronary syndrome (<30 days) or hemodinamic instability
boolean
C0948089 (UMLS CUI [1])
C0948268 (UMLS CUI [2])
Antiplatelet therapy | Exception Aspirin | Thienopyridines | cilostazol | Dipyridamole | Platelet Glycoprotein IIb/IIIA Inhibitors
Item
recent antiplatelet therapy (<14 days), with the exception of asa, including: thienopyridines, cilostazol, dipiridamol, glycoprotein iib/iiia inhibitors
boolean
C1096021 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C2936588 (UMLS CUI [3])
C0055729 (UMLS CUI [4])
C0012582 (UMLS CUI [5])
C1373125 (UMLS CUI [6])
Anticoagulation Therapy Oral | Coumarin Derivative
Item
oral anticoagulation with a coumarin derivative
boolean
C0003281 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0010206 (UMLS CUI [2,1])
C1527240 (UMLS CUI [2,2])
CYP3A4 Inhibitor | Ketoconazole | Clarithromycin | nefazodone | Ritonavir | Atazanavir
Item
concomitant treatment with a potent cyp3a4 inhibitor (e.g. ketoconazole, claritromicine, nefazodone, ritonavir, atazanavir)
boolean
C3830624 (UMLS CUI [1])
C0022625 (UMLS CUI [2])
C0055856 (UMLS CUI [3])
C0068485 (UMLS CUI [4])
C0292818 (UMLS CUI [5])
C1145759 (UMLS CUI [6])
Hemorrhage
Item
any active bleeding
boolean
C0019080 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack | Intracranial Hemorrhages
Item
recent history of stroke, tia or intracranial bleeding (<6 months prior to inclusion)
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0151699 (UMLS CUI [3])
Platelet Count measurement
Item
platelet count <100x106/microl
boolean
C0032181 (UMLS CUI [1])
Chronic Kidney Disease Severe | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
severe chronic kidney disease (creatinine clearance measured with cockcroft-gault formula <30ml/min)
boolean
C1561643 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2711451 (UMLS CUI [2])
Neoplasms
Item
any active neoplasm
boolean
C0027651 (UMLS CUI [1])
Alanine aminotransferase increased
Item
baseline alt >2.5 times the upper limit of normality
boolean
C0151905 (UMLS CUI [1])
Pregnancy | Childbirth
Item
pregnant or childbearing females
boolean
C0032961 (UMLS CUI [1])
C1148523 (UMLS CUI [2])

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