Myocardial Infarction Clinical Trial
Official title:
Comparison of Ticagrelor and Clopidogrel on Reperfusion in Patients With AMI Undergoing PPCI Evaluated by SPECT
The patients with acute myocardial infarction (AMI) present high mortality and morbidity
rate,even treated with stenting in the blocked heart vessels.
The appearance of no-reflow is common after re-opening of the blocked vessel. The no-reflow
were commonly attributed to tiny blockage in coronary micro-vasculature by thrombus and
spasm of the micro-vessel during stenting.
An agent with more effective anti-clotting and micro-vessel dilation would be helpful to
solve the issue of no-reflow. Ticagrelor was demonstrated to be a potent platelet inhibitor
and a potent micro-vessel dilator which can influence metabolism of adenosine, a endogenous
potent small vessel dilator.
This study is to test the effectiveness of ticagrelor on improving reperfusion and
minimizing the myocardial infarct size after PPCI in patients with AMI.
The patients with acute myocardial infarction (AMI) present high mortality and morbidity
rate, and also have malignant prognosis even if they could survive. The mortality and
prognosis has been improved markedly because of the treatment with primary percutaneous
coronary intervention (PPCI). However, the issue of no-reflow after revascularization has
not been solved yet. The mechanisms of no-reflow in human being were regarded mainly as
micro-embolism in coronary micro-circulation with thrombus or debris from atherosclerotic
plaque, coronary micro-vasculature spasm and other conditions.
Therefore, an agent with potent antithrombotic and micro-vasculature dilation function would
be more effective on prevention of no-reflow after coronary revascularization. Ticagrelor
was demonstrated to be a potent platelet inhibitor and a potent micro-vessel dilator which
can influence metabolism of adenosine.
Ticagrelor can inhibit adenosine uptake in vitro and subsequently augments cardiac blood
flow in a canine model of reactive hypoxia- or adenosine-induced blood flow increases. In a
dog coronary thrombosis model, ticagrelor blocks ADP-induced platelet activation and
aggregation; prevents platelet-mediated thrombosis; prolongs reperfusion time and reduces
re-occlusion and cyclic flow variation; and significantly decreases infarct size and rapidly
restores myocardial tissue perfusion. These findings suggest that ticagrelor may have
additional benefits in patients with acute coronary syndrome beyond inhibition of platelet
aggregation, which is advantageous to the dilation of microcirculation and improvement of
myocardial perfusion. AMISTAD study shows that: adenosine reperfusion therapy can reduce 33%
of the infarction area assessed by single-photon emission computed tomography (SPECT)
detection. AMISTAD- 2 study showed that: adenosine early reperfusion therapy can reduce the
composite end point of death and heart failure events. Additionally, ticagrelor is a
non-precursor agent, playing a role directly on platelet inhibition.
Myocardial perfusion imaging with SPECT is among the most widely used and well-established
noninvasive tools for the diagnosis of ischemic coronary disease. It has been shown to have
a high sensitivity and specificity in identifying patients with coronary artery disease and
to be accurate in identifying areas of prior myocardial infarction.
Given the evidence (from PLATO trial) of greater IPA with ticagrelor than clopidogrel,
similar risk of major bleeding and probable effect of micro-vasculature dilation due to
adenosine, ticagrelor will improve the reperfusion and decrease the infarct size
significantly.
This study is to test the effectiveness of ticagrelor on improving reperfusion and
minimizing the myocardial infarct size after PPCI in patients with AMI. Also, it is to
evaluate the safety of ticagrelor in patients with AMI.
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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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