Peripheral arterial vasoactivity in patients with coronary artery disease who have undergone percutaneous coronary intervention MedDRA version: 18.0 Level: LLT Classification code 10068617 Term: Coronary heart disease System Organ Class: 10007541 - Cardiac disorders MedDRA version: 18.0 Level: PT Classification code 10028596 Term: Myocardial infarction System Organ Class: 10007541 - Cardiac disorders MedDRA version: 18.0 Level: HLT Classification code 10011085 Term: Ischaemic coronary artery
Conditions
Interventions
Trade Name: Brilique
Pharmaceutical Form: Coated tablet
Trade Name: Clodel
Pharmaceutical Form: Coated tablet
INN or Proposed INN: clopidogrel
CAS Number: 90055-48-4
Other descriptive name: CLOPIDOGR
Sponsors
Professor Thomas John Kiernan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the peripheral endothelial function of patients on ticagrelor vs. clopidogrel who have undergone percutaneous coronary intervention;Secondary Objective: Not applicable;Primary end point(s): The difference in the proportion of patients with peripheral endothelial dysfunction on ticagrelor versus clopidogrel as measured by the Endo-PAT2000 (Itamar Medical).;Timepoint(s) of evaluation of this end point: After 4 weeks of having either drug administered daily. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Ireland
Contacts
Public ContactUniversity Hospital Limerick
Ronstan Lobo
Outcome results
None listed