Comparing Ticagrelor Versus Clopidogrel on Microcirculation (PLEIO)

February 2, 2018 updated by: Kyungil Park, Dong-A University

A Prospective Randomized Controlled Clinical Trial of Comparing ticagreLor Versus clopidogrEl on mIcrocirculation in Patients With Acute cOronary Syndrome Study

Recently, data (PLATO) from an AstraZeneca study of platelet inhibition and patient outcomes, a Phase III pivotal efficacy and safety study with a duration of up to 12 months comparing ticagrelor 90 mg twice daily dosing to clopidogrel 75 mg once daily dosing in acute coronary syndrome patients on ASA background, have demonstrated superiority of ticagrelor over clopidogrel in the prevention of fatal and non-fatal cardiovascular events. Currently, the mechanism for this mortality reduction remain uncertain. One hypothesis is a adenosine mediated theory that ticagrelor has been shown to enhance adenosine-induced vasodilation. Several experimental and clinical studies support the hypothesis that adenosine could reduce cardiac ischaemia reperfusion damage. Moreover, recent study has demonstrated that ticagrelor enhances adenosine-induced coronary vasodilatory responses in healthy humans. However, there are no available data on coronary circulation effects after chronic treatment of ticagrelor in patients with ACS who have altered resting coronary blood flow dynamics due to advanced coronary artery disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, randomized, open-label, active controlled study with two parallel study groups.

For inclusion in the study subjects should fulfill the following criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Female or male aged 20-85 years
  3. All patients with ACS scheduled for PCI will be eligible, assuming their ability to understand the character and individual consequences of participation as well as giving written informed consent.
  4. Be able to understand and comply with the requirements of the study, as judged by the investigator.

To investigate the effects of ticagrelor on coronary microcirculation, IMR will be measured twice, 6 months apart in the same lesion, compared with clopidogrel.

The IMR is defined as simultaneously measured distal coronary pressure divided by the inverse of the thermodilution-derived hyperaemic mean transit time (Tmn), or more simply, distal coronary pressure multiplied by the Tmn.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

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

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Department of Internal Medicine,Dong-A University College of Medicine

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

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • All patients with ACS scheduled for PCI will be eligible, assuming their ability to understand the character and individual consequences of participation as well as giving written informed consent.
  • Be able to understand and comply with the requirements of the study, as judged by the investigator.

Exclusion Criteria:

  • History of intracranial bleeding
  • Severe hepatic impairment
  • Active pathologic bleeding
  • Hypersensitivity to ticagrelor or any of the excipients
  • Liver cirrhosis greater than or equal to Child class B
  • Decreased serum platelet level (≤ 100,000/uL)
  • Life expectancy ≤ 1 year
  • Need for chronic oral anticoagulant therapy
  • Patients with known bleeding diathesis or coagulation disorder
  • History of previous intracranial bleed at any time, gastrointestinal bleed within the past 6 months, or major surgery within 30 days.
  • Ischemic stroke within the previous 14 days
  • Renal failure requiring dialysis or anticipated need for dialysis during the course of the study
  • Concern for inability of the patient to comply with study procedures and/or follow up
  • Unable to give informed consent.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ticagrelor
Ticagrelor 90mg, twice a day
Drug: Ticagrelor
90mg, twice a day
Active Comparator: Clopidogrel
Clopidogrel 75mg, once a day
Drug: Clopidogrel
75mg, once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Index of microcirculatory resistance using 0.014-in coronary pressure wire
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Fractional flow reserve using 0.014-in coronary pressure wire
Time Frame: 6 months
6 months
Coronary flow reserve using 0.014-in coronary pressure wire
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Dong-A University

Collaborators

AstraZeneca
Biotronik SE & Co. KG

Investigators

  • Study Director: Kyungil Park, MD, Dong-A University

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 (Actual)

December 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

November 27, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 2, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-218

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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