Peripheral Endothelial Function Assessment of Patients on Ticagrelor vs. Clopidogrel Who Have Undergone PCI

NCT02469740 | Completed Phase 4

• 2 other identifiers: RON0042015-000334-30
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Usage of antiplatelet agents and cardiac procedures such as coronary angioplasty has dramatically improved the morbidity and mortality associated with coronary artery disease. In patients with a coronary stent, dual antiplatelet therapy is recommended. Aspirin is the main antiplatelet agent used. For many years, clopidogrel was the second antiplatelet of choice. Recent studies have revealed new antiplatelet drugs that can substitute clopidogrel, one of which is ticagrelor. The degree to which ticagrelor reduced the overall mortality compared to clopidogrel in the PLATO trial suggested that ticagrelor possibly has a pleiotropic effect and that the reduction in mortality is not simply due to its antiplatelet effects. The ticagrelor molecule resembles adenosine. Adenosine has been shown to be cardioprotective. The aim of this project is to study the effects of ticagrelor on the arterial system using a noninvasive method. The study will employ the measurement of peripheral endothelial function of patients who undergo percutaneous coronary intervention who are on ticagrelor vs. clopidogrel using a cross over trial design.

Conditions

Myocardial Ischemia; Coronary Artery Disease; Endothelial Dysfunction

Keywords

Ticagrelor; Clopidogrel; Coronary Artery Disease; Percutaneous Coronary Intervention; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• The number of patients with endothelial dysfunction (Reactive Hyperemia index of < 1.67 using the non-invasive Endo-PAT 2000 device) on ticagrelor versus clopidogrel.

  9 weeks

Study Arms (2)

Ticagrelor

EXPERIMENTAL

Patients in this group will be prescribed ticagrelor 90 mg BD for 4 weeks.

Drug: Ticagrelor

Clopidogrel

ACTIVE COMPARATOR

Patients in this group will be prescribed clopidogrel 75 mg OD for 4 weeks

Drug: Clopidogrel

Interventions

Ticagrelor DRUG

Patients that are randomly selected to receive ticagrelor during the first phase of the study will receive the dose of 90 mg BD orally. This will be continued for 4 weeks before the endothelial function test will be performed. If the patients are assigned in the 2nd phase of the study, they will receive 90 mg BD orally for 5 weeks (4 weeks plus a 1 week washout period).

Also known as: Brilique

Ticagrelor

Clopidogrel DRUG

Patients that are randomly selected to receive ticagrelor during the first phase of the study will receive the dose of 75 mg OD orally. This will be continued for 4 weeks before the endothelial function test will be performed. If the patients are assigned in the 2nd phase of the study, they will receive 75 mg OD orally for 5 weeks (4 weeks plus a 1 week washout period).

Also known as: Plavix, Clodel

Clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Limerick: lead

Study Sites (1)

University Hospital Limerick

Dooradoyle, Limerick, Ireland

Location

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease; Acute Coronary Syndrome

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Thomas J Kiernan

  University Hospital of Limerick

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MB, BCh, BAO (Hons), BMedSc (Hons), MRCPI, MRCP(UK)

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 11, 2015
• Study Start: July 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 11, 2016

Record last verified: 2016-03

Locations

IE (1)