ID

28578

Beskrivning

Clopidogrel and Response Variability Investigation Study 2; ODM derived from: https://clinicaltrials.gov/show/NCT00822666

Länk

https://clinicaltrials.gov/show/NCT00822666

Nyckelord

Versioner (1)
  1. 2018-01-22 2018-01-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 januari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00822666

Engelsk

Eligibility Coronary Artery Disease NCT00822666

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
male gender
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
included in the afiji registry
Beskrivning

Patient Included Other Coding Registry

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0332257
UMLS CUI [1,3]
C3846158
UMLS CUI [1,4]
C0034975
no high bleeding risk profile
Beskrivning

High risk of bleeding Profile Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4039184
UMLS CUI [1,2]
C1979963
UMLS CUI [1,3]
C0332197
no recent history of acute coronary syndrome (< 3 months)
Beskrivning

Acute Coronary Syndrome Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0948089
UMLS CUI [1,2]
C0332197
written informed consent obtained
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
genotype cyp2c19 : *1/*1, *1/*2 ou *2/*2
Beskrivning

CYP2C19 Genotype | CYP2C19*1/*1 | CYP2C19*1/*2 | CYP2C19*2/*2

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1332828
UMLS CUI [1,2]
C0017431
UMLS CUI [2]
C3844564
UMLS CUI [3]
C3844563
UMLS CUI [4]
C3844561
genotype p2y12 : h1/h1 ou h1/h2
Beskrivning

P2Y12 Genotype | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1425330
UMLS CUI [1,2]
C0017431
UMLS CUI [2]
C3846158
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
female gender
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
patient with a contraindication to clopidogrel
Beskrivning

Medical contraindication Clopidogrel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0070166
patient who has received a loading dose of clopidogrel in the past 7 days
Beskrivning

Clopidogrel Loading dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0070166
UMLS CUI [1,2]
C3714444
patient treated with ticlopidine or gp2b/3a receptor antagonist prior to loading
Beskrivning

Ticlopidine | Platelet Glycoprotein IIb/IIIA Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C0040207
UMLS CUI [2]
C1373125
non compliance
Beskrivning

Compliance behavior Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
génotype p2y12 : h2/h2.
Beskrivning

P2Y12 Genotype | Other Coding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1425330
UMLS CUI [1,2]
C0017431
UMLS CUI [2]
C3846158
patient treated with drugs interacting with platelet aggregation (nsaid, persantine, serotonin inhibitors )
Beskrivning

Pharmaceutical Preparations Interaction Platelet aggregation | NSAIDs | Persantine | Serotonin Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0687133
UMLS CUI [1,3]
C0032176
UMLS CUI [2]
C0003211
UMLS CUI [3]
C0700020
UMLS CUI [4]
C0162758
patient treated with drugs interacting 2c19
Beskrivning

Pharmaceutical Preparations Interaction CYP2C19

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0687133
UMLS CUI [1,3]
C0960580
not affiliated to the national health insurance
Beskrivning

National Health Insurance Affiliation Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027452
UMLS CUI [1,2]
C1510825
UMLS CUI [1,3]
C0332197
patient participating to another randomized study
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Coronary Artery Disease NCT00822666

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 18
boolean
C0001779 (UMLS CUI [1])
Gender
Item
male gender
boolean
C0079399 (UMLS CUI [1])
Patient Included Other Coding Registry
Item
included in the afiji registry
boolean
C0030705 (UMLS CUI [1,1])
C0332257 (UMLS CUI [1,2])
C3846158 (UMLS CUI [1,3])
C0034975 (UMLS CUI [1,4])
High risk of bleeding Profile Absent
Item
no high bleeding risk profile
boolean
C4039184 (UMLS CUI [1,1])
C1979963 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Acute Coronary Syndrome Absent
Item
no recent history of acute coronary syndrome (< 3 months)
boolean
C0948089 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent obtained
boolean
C0021430 (UMLS CUI [1])
CYP2C19 Genotype | CYP2C19*1/*1 | CYP2C19*1/*2 | CYP2C19*2/*2
Item
genotype cyp2c19 : *1/*1, *1/*2 ou *2/*2
boolean
C1332828 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C3844564 (UMLS CUI [2])
C3844563 (UMLS CUI [3])
C3844561 (UMLS CUI [4])
P2Y12 Genotype | Other Coding
Item
genotype p2y12 : h1/h1 ou h1/h2
boolean
C1425330 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Gender
Item
female gender
boolean
C0079399 (UMLS CUI [1])
Medical contraindication Clopidogrel
Item
patient with a contraindication to clopidogrel
boolean
C1301624 (UMLS CUI [1,1])
C0070166 (UMLS CUI [1,2])
Clopidogrel Loading dose
Item
patient who has received a loading dose of clopidogrel in the past 7 days
boolean
C0070166 (UMLS CUI [1,1])
C3714444 (UMLS CUI [1,2])
Ticlopidine | Platelet Glycoprotein IIb/IIIA Inhibitors
Item
patient treated with ticlopidine or gp2b/3a receptor antagonist prior to loading
boolean
C0040207 (UMLS CUI [1])
C1373125 (UMLS CUI [2])
Compliance behavior Lacking
Item
non compliance
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
P2Y12 Genotype | Other Coding
Item
génotype p2y12 : h2/h2.
boolean
C1425330 (UMLS CUI [1,1])
C0017431 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Pharmaceutical Preparations Interaction Platelet aggregation | NSAIDs | Persantine | Serotonin Inhibitors
Item
patient treated with drugs interacting with platelet aggregation (nsaid, persantine, serotonin inhibitors )
boolean
C0013227 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C0032176 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2])
C0700020 (UMLS CUI [3])
C0162758 (UMLS CUI [4])
Pharmaceutical Preparations Interaction CYP2C19
Item
patient treated with drugs interacting 2c19
boolean
C0013227 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C0960580 (UMLS CUI [1,3])
National Health Insurance Affiliation Absent
Item
not affiliated to the national health insurance
boolean
C0027452 (UMLS CUI [1,1])
C1510825 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Study Subject Participation Status
Item
patient participating to another randomized study
boolean
C2348568 (UMLS CUI [1])
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