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Comparing Ticagrelor Versus Clopidogrel on Microcirculation (PLEIO)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Sponsored by
Dong-A University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Internal Medicine,Dong-A University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor

Clopidogrel

Arm Description

Ticagrelor 90mg, twice a day

Clopidogrel 75mg, once a day

Outcomes

Primary Outcome Measures

Index of microcirculatory resistance using 0.014-in coronary pressure wire

Secondary Outcome Measures

Fractional flow reserve using 0.014-in coronary pressure wire
Coronary flow reserve using 0.014-in coronary pressure wire

Full Information

First Posted
November 25, 2015
Last Updated
February 2, 2018
Sponsor
Dong-A University
Collaborators
AstraZeneca, Biotronik SE & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT02618733
Brief Title
Comparing Ticagrelor Versus Clopidogrel on Microcirculation
Acronym
PLEIO
Official Title
A Prospective Randomized Controlled Clinical Trial of Comparing ticagreLor Versus clopidogrEl on mIcrocirculation in Patients With Acute cOronary Syndrome Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dong-A University
Collaborators
AstraZeneca, Biotronik SE & Co. KG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: Provision of informed consent prior to any study specific procedures Female or male aged 20-85 years 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
Ticagrelor 90mg, twice a day
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
Clopidogrel 75mg, once a day
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
90mg, twice a day
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
75mg, once a day
Primary Outcome Measure Information:
Title
Index of microcirculatory resistance using 0.014-in coronary pressure wire
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fractional flow reserve using 0.014-in coronary pressure wire
Time Frame
6 months
Title
Coronary flow reserve using 0.014-in coronary pressure wire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyungil Park, MD
Organizational Affiliation
Dong-A University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Internal Medicine,Dong-A University College of Medicine
City
Busan
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
34656119
Citation
Moon H, Jo YS, Kim SJ, Jo S, Park K. Comparison of ticagrelor with clopidogrel on quality of life in patients with acute coronary syndrome. Health Qual Life Outcomes. 2021 Oct 16;19(1):242. doi: 10.1186/s12955-021-01875-w.
Results Reference
derived
PubMed Identifier
32028138
Citation
Jeong YJ, Park K, Kim YD. Comparison between ticagrelor and clopidogrel on myocardial blood flow in patients with acute coronary syndrome, using 13 N-ammonia positron emission tomography. Am Heart J. 2020 Apr;222:121-130. doi: 10.1016/j.ahj.2020.01.013. Epub 2020 Jan 27.
Results Reference
derived
PubMed Identifier
31554423
Citation
Park K, Cho YR, Park JS, Park TH, Kim MH, Kim YD. Comparison of the Effects of Ticagrelor and Clopidogrel on Microvascular Dysfunction in Patients With Acute Coronary Syndrome Using Invasive Physiologic Indices. Circ Cardiovasc Interv. 2019 Oct;12(10):e008105. doi: 10.1161/CIRCINTERVENTIONS.119.008105. Epub 2019 Sep 26.
Results Reference
derived

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Comparing Ticagrelor Versus Clopidogrel on Microcirculation

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