ID

12117

Description

Peripheral Endothelial Function Assessment of Patients on Ticagrelor vs. Clopidogrel Who Have Undergone PCI; ODM derived from: https://clinicaltrials.gov/show/NCT02469740

Link

https://clinicaltrials.gov/show/NCT02469740

Keywords

Versions (1)
  1. 9/24/15 9/24/15 - Julian Varghese
Uploaded on

September 24, 2015

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Myocardial Ischemia NCT02469740

English

Eligibility Myocardial Ischemia NCT02469740

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
Description

able and willing to give written informed consent; study protocol

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subjects must be male or female, aged 18 years or above at baseline
Description

aged 18 years or older; baseline; female

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with coronary artery disease and undergone pci
Description

coronary artery disease; pci

Data type

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2]
C1532338
female subjects of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 12 months (as per guidelines on patients undergoing pci who are on antiplatelet therapy).
Description

Childbearing Potential | Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
female subjects' urine pregnancy test performed at the baseline visit must be negative (which is required by local hospital policy in order to undergo pci).
Description

urine pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0430056
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
allergy/hypersensitivity to study medications or their ingredients
Description

allergy/hypersensitivity to study medications or their ingredients

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3854006
contraindications to either clopidogrel or ticagrelor:
Description

contraindications; clopidogrel; ticagrelor

Data type

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0070166
UMLS CUI [2,1]
C0522473
UMLS CUI [2,2]
C1999375
ticagrelor contraindications - active bleeding, history of intracranial haemorrhage, moderate to severe hepatic impairment, dialysis, uric acid nephropathy, co-administration of a strong cyp3a4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir), history of sick sinus syndrome or high degree av block without pacemaker protection
Description

Hemorrhage | Intracranial Hemorrhages | Hepatic impairment | Dialysis procedure | Urate nephropathy | Cytochrome P450 3A4 Inhibitor | Sick Sinus Syndrome | AV BLOCK HIGH DEGREE

Data type

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C0151699
UMLS CUI [3]
C0948807
UMLS CUI [4]
C0011946
UMLS CUI [5]
C2955673
UMLS CUI [6]
C3830624
UMLS CUI [7]
C0037052
UMLS CUI [8]
C0741311
clopidogrel contraindications - severe hepatic impairment, active bleeding
Description

contraindications; active bleeding; clopidogrel; impairment; hepatic; severe

Data type

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C0948807
on treatment with oral anticoagulant (vitamin k antagonist, dabigatran, rivaroxaban, apixaban)
Description

Anticoagulants, Oral

Data type

boolean

Alias
UMLS CUI [1]
C0354604
unable to follow up in research centre (for example, due to logistic difficulties)
Description

unable to follow up in research centre

Data type

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C1321605
female subjects who are pregnant or breast-feeding, or considering becoming pregnant during the study.
Description

female subjects who are pregnant or breastfeeding.; female subjects who are pregnant or nursing; breast-feeding; study

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147
UMLS CUI [3]
C2081645
subjects who have participated in another study and received any other investigational agent within the previous 12 months
Description

subjects who have participated in another study and received any other investigational agent

Data type

boolean

Alias
UMLS CUI [1]
C2348568
subjects unable to provide written informed consent within 24 hours of pci (for example, intubated patients)
Description

inability to provide written informed consent; able to provide written informed consent; pci

Data type

boolean

Alias
UMLS CUI [1]
C0021430
subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements.
Description

alcohol drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0740858
use of both left and right radial access for pci
Description

use of both left and right radial access for pci

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C3272298
Back to the top of the page

Similar models

Eligibility Myocardial Ischemia NCT02469740

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
able and willing to give written informed consent; study protocol
Item
subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
boolean
C0021430 (UMLS CUI [1])
aged 18 years or older; baseline; female
Item
subjects must be male or female, aged 18 years or above at baseline
boolean
C0001779 (UMLS CUI [1])
coronary artery disease; pci
Item
diagnosed with coronary artery disease and undergone pci
boolean
C0010068 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
Childbearing Potential | Contraceptive methods
Item
female subjects of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 12 months (as per guidelines on patients undergoing pci who are on antiplatelet therapy).
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
urine pregnancy test
Item
female subjects' urine pregnancy test performed at the baseline visit must be negative (which is required by local hospital policy in order to undergo pci).
boolean
C0430056 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
allergy/hypersensitivity to study medications or their ingredients
Item
allergy/hypersensitivity to study medications or their ingredients
boolean
C0020517 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
contraindications; clopidogrel; ticagrelor
Item
contraindications to either clopidogrel or ticagrelor:
boolean
C0522473 (UMLS CUI [1,1])
C0070166 (UMLS CUI [1,2])
C0522473 (UMLS CUI [2,1])
C1999375 (UMLS CUI [2,2])
Hemorrhage | Intracranial Hemorrhages | Hepatic impairment | Dialysis procedure | Urate nephropathy | Cytochrome P450 3A4 Inhibitor | Sick Sinus Syndrome | AV BLOCK HIGH DEGREE
Item
ticagrelor contraindications - active bleeding, history of intracranial haemorrhage, moderate to severe hepatic impairment, dialysis, uric acid nephropathy, co-administration of a strong cyp3a4 inhibitor (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir), history of sick sinus syndrome or high degree av block without pacemaker protection
boolean
C0019080 (UMLS CUI [1])
C0151699 (UMLS CUI [2])
C0948807 (UMLS CUI [3])
C0011946 (UMLS CUI [4])
C2955673 (UMLS CUI [5])
C3830624 (UMLS CUI [6])
C0037052 (UMLS CUI [7])
C0741311 (UMLS CUI [8])
contraindications; active bleeding; clopidogrel; impairment; hepatic; severe
Item
clopidogrel contraindications - severe hepatic impairment, active bleeding
boolean
C0019080 (UMLS CUI [1])
C0948807 (UMLS CUI [2])
Anticoagulants, Oral
Item
on treatment with oral anticoagulant (vitamin k antagonist, dabigatran, rivaroxaban, apixaban)
boolean
C0354604 (UMLS CUI [1])
unable to follow up in research centre
Item
unable to follow up in research centre (for example, due to logistic difficulties)
boolean
C1522577 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
female subjects who are pregnant or breastfeeding.; female subjects who are pregnant or nursing; breast-feeding; study
Item
female subjects who are pregnant or breast-feeding, or considering becoming pregnant during the study.
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C2081645 (UMLS CUI [3])
subjects who have participated in another study and received any other investigational agent
Item
subjects who have participated in another study and received any other investigational agent within the previous 12 months
boolean
C2348568 (UMLS CUI [1])
inability to provide written informed consent; able to provide written informed consent; pci
Item
subjects unable to provide written informed consent within 24 hours of pci (for example, intubated patients)
boolean
C0021430 (UMLS CUI [1])
alcohol drug abuse
Item
subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements.
boolean
C0740858 (UMLS CUI [1])
use of both left and right radial access for pci
Item
use of both left and right radial access for pci
boolean
C1532338 (UMLS CUI [1,1])
C3272298 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial