Differential Effect of Ticagrelor Versus Prasugrel Maintenance Dose on Endothelial Function of Peripheral Vessels in Patients With Coronary Artery Disease

January 8, 2017 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 prospective, randomized study with a crossover design, which will be conducted in patients with CAD under prasugrel maintenance dose (MD) 10mg once a day for at least a 3-month period. At Day 0 (day of randomization) eligible patients will be assigned to either:

  • Ticagrelor 90mg twice a day for the next 15 days or
  • Prasugrel 10mg once a day for the next 15 days At Day 0 (before treatment onset)patients wiil be subjected to a baseline peripheral arterial tonometry measurement. Measurement will be repeated at Day 15 and then treatment crossover will be performed for the next 15 days (without an intervening washout period). At Day 30 patients will be subjected again to peripheral arterial tonometry assessment. Peripheral blood sample will be taken from the patients in Day 0 for genotyping control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

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 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-74 years old
  2. Patients with stable CAD who have been submitted(?) to percutaneous intervention for Acute Coronary Syndrome and receiving prasugrel MD 10mg once a day for at least the previous 3 months.
  3. Patients giving written Informed Consent.

Exclusion Criteria:

  1. Acute Coronary Syndrome

  2. Contraindication for administration of prasugrel or ticagrelor

    1. Known hypersensitivity to clopidogrel or ticagrelor
    2. Active bleeding (peptic ulcer, intracranial bleeding)
    3. Severe liver impairment
    4. Any previous history of intracranial bleeding or transient ischemic attack or ischemic cerebrovascular event
    5. Treatment with potent CYP3A4 inhibitors (ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
  3. Requirement for oral anticoagulant agents prior to the day 30 visit
  4. History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months
  5. Increased risk for bradyarrhythmias, according to the investigator's evaluation
  6. Severe non-controlled chronic obstructive pulmonary disease
  7. Creatinine clearance <30ml/min/1.73mm2
  8. 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ticagrelor
Ticagrelor 90mg bid for 15 days
Drug: Ticagrelor
Drug: Prasugrel
Active Comparator: Prasugrel
Prasugrel 10mg od for 15 days
Drug: Ticagrelor
Drug: Prasugrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reactive Hyperemia Index (RHI) in the 2 subgroups at the end of 2 periods of treatment
Time Frame: 15 days
15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with endothelial dysfunction (RHI<1.67) at the end of 2 periods of treatment
Time Frame: 15 days
15 days

Collaborators and Investigators

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

Sponsor

University of Patras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 30, 2013

First Submitted That Met QC Criteria

September 30, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 8, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PATRASCARDIOLOGY-16

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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