Peripheral vessel function assessment of patients on ticagrelor versus clopidogrel who have undergone coronary angioplasty - a randomized, crossover study

• Conditions: Peripheral arterial vasoactivity in patients with coronary artery disease who have undergone percutaneous coronary intervention; MedDRA version: 18.0Level: LLTClassification code 10068617Term: Coronary heart diseaseSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 18.0Level: PTClassification code 10028596Term: Myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 18.0Level: HLTClassification code 10011085Term: Ischaemic coronary artery disordersSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 18.0Level: LLTClassification code 10069037Term: Drug-eluting coronary stent placementSystem Organ Class: 100000004865; MedDRA version: 18.0Level: LLTClassification code 10028597Term: Myocardial infarction acuteSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2015-000334-30-IE
• Lead Sponsor: Professor Thomas John Kiernan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-05
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable