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

August 19, 2015 updated by: Dimitrios Alexopoulos, University of Patras

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Achaia
      • Patras, Achaia, Greece, 26500
        • Patras University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  1. Age above 18-80 years old
  2. 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.
  3. Patients giving written Informed Consent.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ticagrelor discontinuation
Device: Peripheral arterial tonometry (EndoPAT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reactive Hyperemia Index (RHI) on Day 0 and on Day 5
Time Frame: 5 days
Reactive Hyperemia Index (RHI) on Day 0 will be compared to RHI on Day 5
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reactive Hyperemia Index (RHI) on Day 0 and on Day 2
Time Frame: 2 days
Reactive Hyperemia Index (RHI) on Day 0 will be compared to RHI on Day 2
2 days
Reactive Hyperemia Index (RHI) on Day 2 and on Day 5
Time Frame: 3 days
Reactive Hyperemia Index (RHI) on Day 2 will be compared to RHI on Day 5
3 days
The percentage of patients with RHI<1.67 on Day 0 and on Day 5
Time Frame: 5 days
5 days
The percentage of the patients with RHI<1.67 on Day 0 and on Day 2
Time Frame: 2 days
2 days
The percentage of the patients with RHI<1.67 on Day 2 and on Day 5
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Patras

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 30, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Estimate)

August 20, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PATRASCARDIOLOGY-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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