Unstable Angina Pectoris Clinical Trial
Official title:
The Impact of Administration Strategy of Ticagrelor on Its Pharmacokinetics and Pharmacodynamics in Patients With Unstable Angina Pectoris - a Randomized, Single-center, Open-label Pilot Study
The purpose of this study is to evaluate the differences in pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite depending on the strategy of the drug administration in patients with unstable angina pectoris.
On the basis of the current guidelines ticagrelor is a recommended antiplatelet agent in
acute coronary syndromes, including unstable angina pectoris.
According to the results of the MOJITO study, performed in patients with ST-elevation
myocardial infarction, the effect of ticagrelor, measured as platelet inhibition, may be
achieved sooner when crushed tablets are administered. Thus, there may be significant
differences in pharmacokinetics and pharmacodynamics of ticagrelor if pulverized drug is
given orally or sublingually when compared with currently used oral administration of
integral tablets.
The study is designed as an open-label, single-center, randomized trial of different
strategies of administration of ticagrelor in patients with unstable angina pectoris. After
enrollment, the participants will be randomized into three arms, each receiving ticagrelor.
The drug will be given in: (1) pulverized tablets administered sublingually, (2) pulverized
tablets administered orally or in (3) integral tablets orally. The time required for
ticagrelor and its active metabolite AR-C124900XX to reach their maximum serum concentration
will be measured as the primary outcome of the study. Moreover, further evaluation of other
parameters including maximum plasma concentration and area under the plasma concentration of
ticagrelor and its active metabolite will be assessed as secondary outcomes. The platelet
reactivity will be measured with the Multiplate Analyzer.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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