NCT02612116

Comparison of Administration Strategies of Ticagrelor in Patients With Unstable Angina Pectoris, a Pharmacokinetic / Pharmacodynamic Study

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Collegium Medicum w Bydgoszczy · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Unstable Angina Pectoris

Interventions

Type	Name	Description
DRUG	Pulverized ticagrelor sublingually	Pulverized ticagrelor (180 mg) administered sublingually
DRUG	Pulverized ticagrelor orally	Pulverized ticagrelor (180 mg) administered orally
DRUG	Integral ticagrelor	Integral ticagrelor (180 mg) administered orally

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-08-01
• Completion: 2016-09-01
• First posted: 2015-11-23
• Last updated: 2016-10-19

Locations

1 site across 1 country: Poland