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The purpose of the PINPOINT study is to compare pharmacokinetics (PK) and pharmacodynamics (PD) of ticagrelor in ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) patients designated to invasive strategy. Data regarding comparison of PK and antiplatelet action of ticagrelor in STEMI and NSTEMI are sparse. Recommended dosing regimens of ticagrelor are identical for both STEMI and NSTEMI, although it is not known whether PK and PD features of ticagrelor are uniform in these patients.
The European Society of Cardiology and American Heart Association guidelines recommend use of ticagrelor or prasugrel as a treatment of choice in patients with both STEMI and NSTEMI (class of recommendation I, level of evidence B). Recommended dosing regimens of ticagrelor are identical in STEMI and NSTEMI patients, although epidemiology, clinical approach and early outcomes differ between these two types of myocardial infarction. It is not known whether PK and PD features of ticagrelor are uniform in STEMI and NSTEMI patients. However, the existing body of evidence suggest that PK and PD of ticagrelor may be attenuated in STEMI patients compared to healthy subjects and patients with stable coronary artery disease, which may expose STEMI patients at increased risk of developing thrombotic complications secondary to insufficient platelet inhibition. The PINPOINT study could provide a valuable insight into the knowledge regarding ticagrelor action in STEMI vs. NSTEMI patients.
Since there is no reference study comparing pharmacokinetics of ticagrelor in STEMI and NSTEMI patients, we decided to perform an internal pilot study of approximately 30 patients (15 patients with each type of myocardial infarction) for estimating the final sample size.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STEMI | ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose |
| |
| NSTEMI | non-ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ticagrelor | Drug | 180 mg loading dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h) | prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve for AR-C124910XX (AUC 0-6h) | prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose | |
| Area under the plasma concentration-time curve for ticagrelor (AUC 0-12h) | prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with STEMI or NSTEMI admitted to the study centre, designated to invasive strategy.
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| Name | Affiliation | Role |
|---|---|---|
| Jacek Kubica, MD, PhD | Collegium Medicum, Nicolaus Copernicus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology Department, Dr. A. Jurasz University Hospital | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-094 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29023473 | Derived | Adamski P, Sikora J, Laskowska E, Buszko K, Ostrowska M, Uminska JM, Sikora A, Skibinska N, Sobczak P, Adamska U, Rosc D, Kubica A, Paciorek P, Marszall MP, Navarese EP, Gorog DA, Kubica J. Comparison of bioavailability and antiplatelet action of ticagrelor in patients with ST-elevation myocardial infarction and non-ST-elevation myocardial infarction: A prospective, observational, single-centre study. PLoS One. 2017 Oct 12;12(10):e0186013. doi: 10.1371/journal.pone.0186013. eCollection 2017. | |
| 28446521 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Area under the plasma concentration-time curve for AR-C124910XX (AUC 0-12h) | prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose |
| Maximum concentration (Cmax) of ticagrelor and AR-C124910XX | 12 hours |
| Time to maximum concentration (Cmax) for ticagrelor and AR-C124910XX | 12 hours |
| Platelet reactivity index (PRI) assessed by VASP assay | prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose |
| Platelet reactivity assessed by Multiple Electrode Aggregometry | It will be assessed in all predefined time points in all study participants except those treated with GP IIb/IIIa receptor inhibitors. | prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose |
| Percentage of patients with high platelet reactivity (HPR) after the loading dose of ticagrelor assessed with VASP and Multiple Electrode Aggregometry | 2 hours |
| Time to reach platelet reactivity below the cut-off value for HPR evaluated with VASP and Multiple Electrode Aggregometry | 12 hours |
| Derived |
| Adamski P, Ostrowska M, Sikora J, Obonska K, Buszko K, Krintus M, Sypniewska G, Marszall MP, Kozinski M, Kubica J. Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in STEMI and NSTEMI Patients (PINPOINT): protocol for a prospective, observational, single-centre study. BMJ Open. 2017 Apr 26;7(4):e013218. doi: 10.1136/bmjopen-2016-013218. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |