Acute Coronary Syndrome Clinical Trial
Study design Investigators aim to perform a prospective, single-center,
investigator-initiated, randomized study to compare the Adenosine-induced coronary
vasodilatation after the loading dose of Ticagrelor either Prasugrel during the Percutaneous
Coronary Intervention. Patients with acute coronary syndrome undergoing Percutaneous
Coronary Intervention will be enrolled in the study and will be randomized, in a 1:1 ratio,
to receive a loading dose of Ticagrelor (180 mg) or Prasugrel (60 mg). In patients with
non-ST elevation myocardial infarction these drugs will be administered only when the
coronary anatomy will be known, to avoid bleeding due to prasugrel, in patients suitable for
coronary artery bypass grafting as recommended by European Society of Cardiology guidelines
(Class IB) (10). In patients with ST elevation myocardial infarction, instead, prasugrel and
ticagrelor will be administrated before the procedure, according to the European Society of
Cardiology guidelines (Class IB) (11). Coronary Flow Reserve will be recorded by
intracoronary Doppler Flow Wire before the stent implantation and after the procedure at
baseline and 2-minute later adenosine intravenous administration at incremental doses of 50,
80, 110 and 140 ug/Kg/min with 2 minutes interval between infusions.
Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to
maximal exercise. Doppler Flow Wire allows to measure this increase expressing it as a ratio
between maximal vasodilation and flow at rest. Coronary Flow Reserve is routinely measured
in patients with acute coronary syndrome, without an increased risk of adverse events for
patients neither adjunctive costs for the National Health System.
Furthermore, Plasma concentrations of Ticagrelor and its main metabolite (AR-C124910XX) will
be measured in venous blood collected at the end of the procedure. . In patients requiring a
second Percutaneous Coronary Intervention, for example for multivessel disease, all these
measures will be repeated in the same manner.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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