Offset of Ticagrelor's Effect on Endothelial Function as Assessed With Peripheral Arterial Tonometry (EndoPAT Assay)

NCT01957527 | Completed

• 1 other identifier: PATRASCARDIOLOGY-15
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall mortality and thrombotic cardiovascular (CV) events when directly compared to clopidogrel in the PLATO trial, implicating possible pleiotropic actions for the drug. It has been shown that ticagrelor increases adenosine concentration, by interfering with its red blood cells' uptake and by inducing the release of ATP which is then converted to adenosine. Recent studies in healthy volunteers and patients with coronary artery disease (CAD) have shown that ticagrelor increases the coronary blood flow in response to intravenous adenosine administration. Ticagrelor administration, in comparison with other P2Y12 inhibitors, may influence the endothelial function, as assessed by the Peripheral Arterial Tonometry method (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is a method for evaluating endothelial dysfunction and has been found to positively correlate with flow mediated dilatation (FMD). This is a prospective, observational study, which will be conducted in patients with coronary artery disease subjected to percutaneous coronary intervention (PCI) under ticagrelor maintenance dose (MD) 90mg x 2, who are about to stop treatment, due to completion of 1 year antiplatelet therapy. Eligible patients will be subjected to peripheral arterial tonometry at Day 0 (immediately after receiving the last pill of ticagrelor) and at day 2 and day 5 post study drug discontinuation. Peripheral blood sample will be taken from the patients at Day 0 for genotype analysis.

Conditions

Coronary Artery Disease; Endothelial Function

Keywords

ticagrelor; endothelial function; peripheral arterial tonometry

Outcome Measures

Primary Outcomes (1)

• Reactive Hyperemia Index (RHI) on Day 0 and on Day 5

  Reactive Hyperemia Index (RHI) on Day 0 will be compared to RHI on Day 5

  5 days

Secondary Outcomes (5)

• Reactive Hyperemia Index (RHI) on Day 0 and on Day 2

  2 days

• Reactive Hyperemia Index (RHI) on Day 2 and on Day 5

  3 days

• The percentage of patients with RHI<1.67 on Day 0 and on Day 5

  5 days

• The percentage of the patients with RHI<1.67 on Day 0 and on Day 2

  2 days

• The percentage of the patients with RHI<1.67 on Day 2 and on Day 5

  3 days

Study Arms (1)

Ticagrelor discontinuation

Device: Peripheral arterial tonometry (EndoPAT)

Interventions

Peripheral arterial tonometry (EndoPAT) DEVICE

Ticagrelor discontinuation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with coronary artery disease under ticagrelor maintenance dose, who are about to discontinue ticagrelor, due to completion of 12 months dual antiplatelet therapy.

You may qualify if:

• Age above 18-80 years old
• Patients with Coronary Artery Disease receiving ticagrelor maintenance dose (MD) 90mg x 2 and are about to discontinue the treatment due to the completion of 1 year of dual antiplatelet therapy.
• Patients giving written Informed Consent.

You may not qualify if:

• Acute Coronary Syndrome
• Foreseeable need for anticoagulant treatment within the next 5 days
• Severe non-regulated with theophylline/aminophylline administration chronic obstructive pulmonary disease
• Creatinine Clearance \<30ml/min/1.73mm2
• HbA1c \> 10mg/dl

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Patras University Hospital

Pátrai, Achaia, 26500, Greece

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 8, 2013
• Study Start: June 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 20, 2015

Record last verified: 2015-08

Locations

GR (1)