Unstable Angina Pectoris Clinical Trial
Official title:
Differences in the Pharmacokinetic and Pharmacodynamic Profile of Ticagrelor and Its Active Metabolite AR-C124900XX Between Patients With Unstable Angina Pectoris Treated With Crushed Ticagrelor and a Combination of Morphine and Naloxone or Morphine Alone - a Randomized Study
The purpose of this study is to evaluate differences in the pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite between patients who received ticagrelor and morphine followed by naloxone versus patients treated with ticagrelor and morphine alone for unstable angina pectoris.
According to contemporary guidelines, ticagrelor is a recommended antiplatelet agent in acute
coronary syndromes, including unstable angina pectoris. Quick platelet inhibition plays
pivotal role in the treatment of acute coronary syndromes. As evidenced in the IMPRESSION
study, analgesia with morphine delays platelet inhibition in patients with acute myocardial
infarction. On the other hand, the results of the MOJITO study prove that administration of
crushed ticagrelor tablets leads to quicker platelet blockage.
Taking the above into consideration, we created a pharmacokinetic/pharmacodynamic study
aiming to evaluate differences between patients who received crushed ticagrelor orally
followed by either 1) a combination of intravenous morphine and orally administered naloxone
or 2) intravenous morphine alone.
The primary study outcome is time needed for ticagrelor and its active metabolite to reach
their maximum plasma concentration in each study arm. Secondary outcomes include ticagrelor
and AR-C124900XX maximum concentration and the area under the plasma concentration curve for
both agents.
Platelet reactivity will be assessed with the Multiplate Analyzer in all study participants
at nine predefined time points.
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