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Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in STEMI and NSTEMI Patients (PINPOINT): protocol for
Piotr Adamski1, Małgorzata Ostrowska1, Joanna Sikora2
1Department of Principles of Clinical Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland.
Insights
This study compares ticagrelor pharmacokinetics in ST-elevation myocardial infarction (STEMI) versus non-ST-elevation myocardial infarction (NSTEMI) patients. It investigates if STEMI affects ticagrelor concentration and antiplatelet effects, crucial for treatment optimization.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Acute myocardial infarction (AMI) is classified as STEMI or NSTEMI, with differing clinical approaches and outcomes.
- Ticagrelor is a first-line P2Y12 inhibitor for both STEMI and NSTEMI.
- Existing data suggest potential differences in early ticagrelor plasma concentrations between STEMI and NSTEMI, but direct comparative studies are lacking.
Purpose of the Study:
- To compare the pharmacokinetics and pharmacodynamics of ticagrelor in patients with STEMI versus NSTEMI.
- To investigate potential differences in ticagrelor absorption and antiplatelet effect based on AMI type.
- To inform optimal therapeutic strategies for ticagrelor in different AMI classifications.
Main Methods:
- Phase IV, prospective, observational, single-centre study (PINPOINT).
- Inclusion of at least 23 patients with STEMI and 23 with NSTEMI, all receiving a 180 mg ticagrelor loading dose.
- Primary endpoint: Area Under the Curve (AUC(0-6)) of ticagrelor plasma concentration in the first 6 hours; secondary endpoints include metabolite levels and platelet reactivity assays.
Main Results:
- The study is registered (NCT02602444) and is currently in the pre-results phase.
- Pharmacokinetic and pharmacodynamic data will be collected at multiple time points post-dose.
- Analysis will focus on comparing AUC(0-6), other pharmacokinetic parameters, and platelet inhibition between STEMI and NSTEMI groups.
Conclusions:
- The study aims to provide the first direct comparison of ticagrelor pharmacokinetics and pharmacodynamics in STEMI versus NSTEMI.
- Findings are expected to clarify if STEMI influences ticagrelor's early effectiveness.
- Results will be disseminated via publications and presentations to guide clinical practice.
Introduction:
The most common classification of acute myocardial infarction (AMI) is based on electrocardiographic findings and distinguishes ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI). Both types of AMI differ concerning their epidemiology, clinical approach and early outcomes. Ticagrelor is a P2Y12 receptor inhibitor, constituting the first-line treatment for STEMI and NSTEMI. According to available data, STEMI may be associated with lower plasma concentration of ticagrelor in the first hours of AMI, but currently there are no studies directly comparing ticagrelor pharmacokinetics or antiplatelet effect in patients with STEMI versus NSTEMI.
Methods And Analysis:
The PINPOINT study is a phase IV, single-centre, investigator-initiated, prospective, observational study designed to compare the pharmacokinetics and pharmacodynamics of ticagrelor in patients with STEMI and NSTEMI assigned to the invasive strategy of treatment. Based on an internal pilot study, the trial is expected to include at least 23 patients with each AMI type. All subjects will receive a 180 mg loading dose of ticagrelor. The primary end point of the study is the area under the plasma concentration-time curve (AUC(0-6)) for ticagrelor during the first 6 hours after the loading dose. Secondary end points include various pharmacokinetic features of ticagrelor and its active metabolite (AR-C124910XX), and evaluation of platelet reactivity by the vasodilator-stimulated phosphoprotein assay and multiple electrode aggregometry. Blood samples for the pharmacokinetic and pharmacodynamic assessment will be obtained at pretreatment, 30 min, 1, 2, 3, 4, 6 and 12 hours post-ticagrelor loading dose.
Ethics And Dissemination:
The study received approval from the Local Ethics Committee (Komisja Bioetyczna Uniwersytetu Mikołaja Kopernika w Toruniu przy Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy; approval reference number KB 617/2015). The study results will be disseminated through conference presentations and peer-reviewed journals.
Trial Registration Number:
NCT02602444; Pre-results.
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