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])
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])