Efficacy of Ticagrelor vs Clopidogrel in High-risk NSTE-ACS Patients Undergoing Early PCI
Status:
Unknown status
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
The goal of acute coronary syndrome (ACS) therapy is to successfully restore both epicardial
blood flow and myocardial perfusion. Percutaneous coronary intervention (PCI) has been
documented as being the most effective method for restoration of epicardial blood flow.
However, epicardial blood flow does not necessarily equate to myocardial perfusion.
Clopidogrel binds irreversibly to platelet P 2 Y 12 receptors to inhibit platelet
aggregation, with main limitations of slow onset, prevention of recovery of platelet
functions, and interindividual variability. Clinical pharmacology and early dose-finding
studies suggested a faster onset and greater and more consistent inhibition of platelet
aggregation (IPA) with ticagrelor compared with clopidogrel. Two currently main methods of
angiographic assessment of myocardial perfusion includes thrombolysis in myocardial
infarction(TIMI) myocardial perfusion grading (TMPG) and myocardial blush grading (MBG).
These established myocardial perfusion parameters have been widely used in various important
trials and are reported to be highly useful in predicting clinical outcomes. However, visual
assessment of these methods is categorical, subjective, and operator dependent of contrast in
the myocardium using cine-angiographic frame-counting, was developed by the investigators'
center to quantify myocardial tissue- level perfusion and was proved to be a predictive value
on clinical prognosis.
Thus, the investigators aim to initiate an open-label study evaluating the acute efficacy of
treatment with ticagrelor versus clopidogrel on myocardial tissue-level perfusion assessed by
Myocardial Perfusion Frame Count(TMPFC) and magnetic resonance imaging (MRI) in patients with
high-risk non-ST elevation acute coronary syndrome (NSTE-ACS) undergoing early percutaneous
coronary intervention (PCI) .
The investigators hypothesize that compared with clopidogrel, ticagrelor can significantly
improve myocardial perfusion assessed by Myocardial Perfusion Frame Count(TMPFC) in high-risk
non-ST elevation acute coronary syndrome (NSTE-ACS) patients undergoing early percutaneous
coronary intervention (PCI), without additional increased major bleeding.