Cardiovascular Diseases Clinical Trial
Official title:
Which Platelet Function Test Provides the Best Reflection of the in Vivo Plasma Concentrations of Ticagrelor and Its Active Metabolite? A Pharmacokinetic and Pharmacodynamic Study Including Patients With Myocardial Infarction.
Ticagrelor is a direct-acting, reversible platelet P2Y12 receptor inhibitor recommended by
the recent European Society of Cardiology guidelines in patients with acute coronary
syndromes (ACS) (class of recommendation I, level of evidence B). Ticagrelor inhibits
platelet function stronger, faster and more consistently than clopidogrel, the former
standard of antiplatelet therapy. In the landmark PLATO trial (Study of PLATelet inhibition
and patient Outcomes), ticagrelor therapy as compared with clopidogrel treatment was
associated with the reduced occurrence of major adverse cardiovascular events and all-cause
mortality, but also resulted in a small, but statistically significant, increase in the rate
of major bleeding. The optimum choice of antiplatelet treatment, aimed to provide each
patient with maximum protection against ischemic events, while minimizing the risk of
bleeding complications, is the challenge of contemporary ACS therapy. The tool which may
help physicians and facilitate clinical decision making is platelet function testing.
According to the guidance of both European and American groups of experts, there are three
currently recommended platelet function tests, namely the VerifyNow device, the Multiplate
analyzer and the Vasodilator Stimulated Phosphoprotein Phosphorylation (VASP) assay. It
needs to be emphasized that none of these three methods is preferred over others. So far
there are no studies linking pharmacokinetic analysis of ticagrelor and its active
metabolite with comparative evaluation of platelet reactivity. The aim of this trial is to
assess the relationship between concentrations of ticagrelor and its active metabolite
(AR-C124910XX) and results of all three recommended platelet function tests in patients with
myocardial infarction. Patients who receive GP IIb/IIIa receptor inhibitor will be excluded
from the primary analysis.
Statistical analysis: The correlation will be assessed using correlation coefficients and
intraclass correlation coefficients. while the agreement between the results of the compared
platelet function tests will be measured using the Kappa statistic and Bland-Altman
analysis.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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