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Effect of Free Ticagrelor Fraction on Platelet Membrane Post MI (PLATIME)

29. januar 2021 opdateret af: Centre Hospitalier Universitaire de Besancon

Population-Based Pharmacokinetic / Pharmacodynamic Modeling of the Effect of Free Ticagrelor Fraction on the Platelet Membrane in Post Myocardial Infarction Patients

The purpose of this study is to assess:

  • the population pharmacokinetics of unbound ticagrelor and its metabolite in acute coronary syndrome patients treated by ticagrelor
  • ticagrelor and its metabolite levels by LC-MS/MS

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Ticagrelor is an anti-platelet agent of the cyclopentyltriazolopyrimidine class. It is administered by the oral route, rapidly absorbed (2-3 hours), and has a bio-availability estimated at around 36%. Contrary to other P2Y12 inhibitors, ticagrelor is not a pro-drug and does not need to be metabolized to exert is pharmacodynamic effect. It had been previously showed that stimulation of platelets by ADP or inhibitors of platelets by ticagrelor modified the organisation of the platelet membrane, with a re-distribution of cholesterol and P2Y12 receptors towards the lipid rafts. This suggests that lipid membranes and cholesterol may play an important role in the anti-platelet activity of ticagrelor.

In this context, the aim of the study is to assess:

  • the population pharmacokinetics of unbound ticagrelor and its metabolite in acute coronary syndrome patients treated by ticagrelor
  • ticagrelor and its metabolite levels by LC-MS/MS.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

30

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Frankrig
      • Besançon, Frankrig, 25000
        • Rekruttering
        • CHU Besançon

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 til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients admitted to the Cardiology department with a main diagnosis of acute coronary syndrome and treated with a treatment combination including ticagrelor and aspirin.

Beskrivelse

Inclusion Criteria:

  • Patients aged over 18 years and less than 90 years,
  • Patients admitted for myocardial infarction treated with ticagrelor in association with aspirin.
  • Patients affiliated to a social security system (or be a beneficiary thereof);
  • Sign written informed consent indicating that they have understood the study procedures and objectives, and that they accept to participate and adhere to the study requirements.

Exclusion Criteria:

  • Patients with limited legal capacity or patients under legal guardianship
  • Patients under judicial protection
  • Patients not affiliated to any social security system
  • Patients taking any antiplatelet agent other than ticagrelor Patients taking ticagrelor for <48 hours (treatment not stabilised) Patients with hemoglobin concentration <10 g/dL on the most recent blood test

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Study cohort

Adult (>18 years, <90 years) patients admitted and treated for acute myocardial infarction, and whose treatment includes ticagrelor in association with aspirin.

Blood samples will be taken at 3 timepoints between two doses of ticagrelor (taken at 12 hours interval).
Andet: Blood sample
3 blood samples, for a maximum of 60mL, will be taken at 0-3h, 3-6h and >6h, between two doses of ticagrelor (taken at 0 and 12 hours).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
concentration of unbound ticagrelor and its metabolite
Tidsramme: at 3 hours after administration of the first dose of ticagrelor
Concentration of unbound ticagrelor and its active metabolite in acute coronary syndrome patients treated by ticagrelor and aspirin
at 3 hours after administration of the first dose of ticagrelor
concentration of unbound ticagrelor and its metabolite
Tidsramme: at 6 hours after administration of the first dose of ticagrelor
Concentration of unbound ticagrelor and its active metabolite in acute coronary syndrome patients treated by ticagrelor and aspirin
at 6 hours after administration of the first dose of ticagrelor
concentration of unbound ticagrelor and its metabolite
Tidsramme: at 12 hours after administration of the first dose of ticagrelor
Concentration of unbound ticagrelor and its active metabolite in acute coronary syndrome patients treated by ticagrelor and aspirin
at 12 hours after administration of the first dose of ticagrelor

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assess the method of determination of ticagrelor concentration
Tidsramme: at 3 hours after administration of the first dose of ticagrelor
Identify the optimum settings for the measurement of the concentration of ticagrelor (total and free fraction) and its active metabolite in the plasma by LC-MS/MS
at 3 hours after administration of the first dose of ticagrelor
Assess the method of determination of ticagrelor concentration
Tidsramme: at 6 hours after administration of the first dose of ticagrelor
Identify the optimum settings for the measurement of the concentration of ticagrelor (total and free fraction) and its active metabolite in the plasma by LC-MS/MS
at 6 hours after administration of the first dose of ticagrelor
Assess the method of determination of ticagrelor concentration
Tidsramme: at 12 hours after administration of the first dose of ticagrelor
Identify the optimum settings for the measurement of the concentration of ticagrelor (total and free fraction) and its active metabolite in the plasma by LC-MS/MS
at 12 hours after administration of the first dose of ticagrelor

Samarbejdspartnere og efterforskere

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

Sponsor

Centre Hospitalier Universitaire de Besancon

Efterforskere

  • Ledende efterforsker: Nicolas Meneveau, MD, PhD, Dept of Cardiology, CHU Besancon

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)

9. april 2019

Primær færdiggørelse (Forventet)

9. april 2022

Studieafslutning (Forventet)

9. april 2022

Datoer for studieregistrering

Først indsendt

12. juli 2018

Først indsendt, der opfyldte QC-kriterier

3. september 2018

Først opslået (Faktiske)

5. september 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P/2018/371

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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