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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Impact of Administration Strategy of Ticagrelor on Its Pharmacokinetics and Pharmacodynamics in Patients With Unstable Angina Pectoris - a Randomized, Single-center, O

Brief 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 Summary:

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.


Sponsor: Collegium Medicum w Bydgoszczy

Current Primary Outcome: Time to maximum concentration (tmax) for ticagrelor and AR-C124900XX [ Time Frame: 6 hours ]

Original Primary Outcome: Time to maximum concentration (tmax) for ticagrelor and AR-C124900XX [ Time Frame: 6h ]

Current Secondary Outcome:

  • Maximum ticagrelor and AR-C124900XX concentration [ Time Frame: 6 hours ]
  • Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h) [ Time Frame: prior to the initial dose and 15 min, 30 min, 45 min, 1, 2, 3, 4, 6 hours post dose ]
  • Area under the plasma concentration-time curve for AR-C124900XX (AUC 0-6h) [ Time Frame: prior to the initial dose and 15 min, 30 min, 45 min, 1, 2, 3, 4, 6 hours post dose ]
  • Platelet reactivity assessed by Multiple Electrode Aggregometry [ Time Frame: prior to the initial dose and 30min, 1, 2, 3, 4, 6 hours post dose ]


Original Secondary Outcome:

  • Maximum ticagrelor and AR-C124900XX concentration [ Time Frame: 6h ]
  • Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h) [ Time Frame: prior to the initial dose and 15 min, 30 min, 45 min, 1h, 2h, 3h, 4h, 6h post dose ]
  • Area under the plasma concentration-time curve for AR-C124900XX (AUC 0-6h) [ Time Frame: prior to the initial dose and 15 min, 30 min, 45 min, 1h, 2h, 3h, 4h, 6h post dose ]
  • Platelet reactivity assessed by Multiple Electrode Aggregometry [ Time Frame: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose ]


Information By: Collegium Medicum w Bydgoszczy

Dates:
Date Received: November 19, 2015
Date Started: September 2015
Date Completion:
Last Updated: October 18, 2016
Last Verified: October 2016