Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 4:40 PM
Study NCT ID:
NCT02618733
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2015-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Ticagrelor Versus Clopidogrel on Microcirculation
Sponsor:
Dong-A University
Organization:
Study Overview
Official Title:
A Prospective Randomized Controlled Clinical Trial of Comparing ticagreLor Versus clopidogrEl on mIcrocirculation in Patients With Acute cOronary Syndrome Study
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLEIO
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:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: