Acute Coronary Syndrome Clinical Trial
Official title:
An Open-label Study Evaluating the Acute Efficacy of Treatment With Ticagrelor Versus Clopidogrel on Myocardial Tissue-level Perfusion Assessed by TMPFC and MRI in Patients With High-risk NSTE-ACS Undergoing Early PCI(EARLY-MYO II)
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.
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; not
every patient with thrombolysis in myocardial infarction(TIMI) 3 flow after successful
percutaneous coronary intervention (PCI) achieves effective myocardial tissue-level
perfusion. Although epicardial thrombolysis in myocardial infarction(TIMI) 3 flow could be
restored in >90% of acute coronary syndrome (ACS) patients undergoing percutaneous coronary
intervention (PCI) , normalization of myocardial perfusion was achieved less frequently,
with detrimental impacts on survival.
Clopidogrel, the most widely used antiplatelet agent in acute coronary syndrome (ACS), is a
thienopyridine prodrug, which is inactive until in undergoes biotransformation into its
active metabolite, which then binds irreversibly to platelet P 2 Y 12 receptors. This
irreversible binding means that the receptors are inhibited for the lifespan of the
platelet. The main limitations of clopidogrel administration include 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. ONSET/OFFSET study showed that in patients with stable coronary artery disease
on aspirin, ticagrelor demonstrates a rapid onset of pharmacological effect, as demonstrated
by a mean platelet aggregation (IPA) for ticagrelor at 0.5 h after 180 mg loading dose of
about 41%, with the maximum platelet aggregation (IPA) effect of 87.9-89.6% by 2-4 hours
post dose. A total of 90% of patients had final extent Inhibition of platelet aggregation
(IPA) >70% by 2 h post-dose. The high inhibition of platelet aggregation (IPA) effect of
ticagrelor (between 87% and 89%) was maintained for 2-8 hours. Ticagrelor might overcome the
slow-onset limitation of clopidogrel and bring extra benefit for improving myocardial
perfusion in the acute phase of acute coronary syndrome (ACS) when undergoing early
percutaneous coronary intervention (PCI).
Currently, there are two main methods of angiographic assessment of myocardial perfusion:
Thrombolysis in myocardial infarction (TIMI) myocardial perfusion grading (TMPG), described
by Gibson et al. and myocardial blush grading (MBG), described by Van't Hof et al. These
established myocardial perfusion parameters, myocardial perfusion grading (TMPG), and
myocardial blush grading (MBG), 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. Thrombolysis in myocardial
infarction(TIMI) Myocardial Perfusion Frame Count (TMPFC), a novel and objective method that
measures the filling and clearance 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).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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