ID

35581

Beschrijving

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

Trefwoorden

Versies (1)
  1. 11-03-19 11-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 maart 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02457130

Engels

Eligibility Coronary Artery Disease NCT02457130

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Informed Consent

Datatype

boolean

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

Age

Datatype

boolean

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

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
angiographically documented cad
Beschrijving

Coronary Artery Disease Angiography

Datatype

boolean

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

Aspirin chronic

Datatype

boolean

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

Exclusion Criteria

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

Aspirin allergy | Hypersensitivity Clopidogrel | Hypersensitivity Ticagrelor

Datatype

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
Beschrijving

Hematological Disease

Datatype

boolean

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

Acute Coronary Syndrome | Hemodynamic instability

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Anticoagulation Therapy Oral | Coumarin Derivative

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

Hemorrhage

Datatype

boolean

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

Cerebrovascular accident | Transient Ischemic Attack | Intracranial Hemorrhages

Datatype

boolean

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

Platelet Count measurement

Datatype

boolean

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

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

Datatype

boolean

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

Neoplasms

Datatype

boolean

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

Alanine aminotransferase increased

Datatype

boolean

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

Pregnancy | Childbirth

Datatype

boolean

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

Eligibility Coronary Artery Disease NCT02457130

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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