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Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in STEMI and NSTEMI Patients (PINPOINT)

26. april 2017 opdateret af: Jacek Kubica, Collegium Medicum w Bydgoszczy

Comparison of Ticagrelor Pharmacokinetics and Pharmacodynamics in ST-elevation Myocardial Infarction and Non-ST-elevation Myocardial Infarction Patients

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

73

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Polen
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Polen, 85-094
        • Cardiology Department, Dr. A. Jurasz University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients with STEMI or NSTEMI admitted to the study centre, designated to invasive strategy.

Beskrivelse

Inclusion Criteria:

  • provision of informed consent prior to any study specific procedures
  • diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction
  • male or non-pregnant female, 18 years old and older
  • provision of informed consent for angiography and PCI

Exclusion Criteria:

  • treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
  • hypersensitivity to ticagrelor
  • current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
  • active bleeding
  • history of intracranial hemorrhage
  • recent gastrointestinal bleeding (within 30 days)
  • history of coagulation disorders
  • history of moderate or severe hepatic impairment
  • history of major surgery or severe trauma (within 3 months)
  • second or third degree atrioventricular block during screening for eligibility
  • patient required dialysis
  • manifest infection or inflammatory state
  • Killip class III or IV during screening for eligibility
  • respiratory failure
  • current therapy with strong CYP3A inhibitors or strong CYP3A inducers

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
STEMI
ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose
Medicin: ticagrelor
180 mg loading dose
Andre navne:
  • Brilique
NSTEMI
non-ST-elevation myocardial infarction patients receiving 180 mg ticagrelor loading dose
Medicin: ticagrelor
180 mg loading dose
Andre navne:
  • Brilique

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Area under the plasma concentration-time curve for ticagrelor (AUC 0-6h)
Tidsramme: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area under the plasma concentration-time curve for AR-C124910XX (AUC 0-6h)
Tidsramme: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose
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)
Tidsramme: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Area under the plasma concentration-time curve for AR-C124910XX (AUC 0-12h)
Tidsramme: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Maximum concentration (Cmax) of ticagrelor and AR-C124910XX
Tidsramme: 12 hours
12 hours
Time to maximum concentration (Cmax) for ticagrelor and AR-C124910XX
Tidsramme: 12 hours
12 hours
Platelet reactivity index (PRI) assessed by VASP assay
Tidsramme: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
Platelet reactivity assessed by Multiple Electrode Aggregometry
Tidsramme: prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose
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
Tidsramme: 2 hours
2 hours
Time to reach platelet reactivity below the cut-off value for HPR evaluated with VASP and Multiple Electrode Aggregometry
Tidsramme: 12 hours
12 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Collegium Medicum w Bydgoszczy

Efterforskere

  • Ledende efterforsker: Jacek Kubica, MD, PhD, Collegium Medicum, Nicolaus Copernicus University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2015

Primær færdiggørelse (Faktiske)

1. januar 2017

Studieafslutning (Faktiske)

1. januar 2017

Datoer for studieregistrering

Først indsendt

9. november 2015

Først indsendt, der opfyldte QC-kriterier

9. november 2015

Først opslået (Skøn)

11. november 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CMUMK202B

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Myokardieinfarkt

Kliniske forsøg med ticagrelor

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Placeringer

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