Comparing Ticagrelor Versus Clopidogrel on Microcirculation (PLEIO)

Dong-A University

Status

Completed

Conditions

Acute Coronary Syndrome

Treatments

Drug: Ticagrelor

Drug: Clopidogrel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02618733

14-218

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No 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.