Peripheral endothelial function assessment of patients on ticagrelor versus clopidogrel who have undergone percutaneous coronary intervention - a randomized, crossover study

Professor Thomas John Kiernan0 个研究点开始时间: 2015年3月5日最近更新: 2015年7月10日

适应症

试验速览

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•Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
•Subjects must be male or female, aged 18 years or above at baseline
•Diagnosed with coronary artery disease and undergone PCI
•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).
•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).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•Allergy/hypersensitivity to study medications or their ingredients
•Contraindications to either clopidogrel or ticagrelor:
•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
•Clopidogrel contraindications – severe hepatic impairment, active bleeding
•On treatment with oral anticoagulant (vitamin K antagonist, dabigatran, rivaroxaban, apixaban)
•Unable to follow up in research centre (for example, due to logistic difficulties)
•Female subjects who are pregnant or breast-feeding, or considering becoming pregnant during the study.
•Subjects who have participated in another study and received any other investigational agent within the previous 12 months
•Subjects unable to provide written informed consent within 24 hours of PCI (for example, intubated patients)
•Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements.
•Use of both left and right radial access for PCI

发起方

Professor Thomas John Kiernan