Effect of Free Ticagrelor Fraction on Platelet Membrane Post MI (PLATIME)
29. januar 2021 oppdatert av: 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
Studieoversikt
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Forventet)
30
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jennifer Lagoutte-Renosi, MPharm
- Telefonnummer: +33370632379
- E-post: jlagoutte@chu-besancon.fr
Studiesteder
-
-
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Besançon, Frankrike, 25000
- Rekruttering
- CHU Besançon
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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). |
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).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Nicolas Meneveau, MD, PhD, Dept of Cardiology, CHU Besancon
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
9. april 2019
Primær fullføring (Forventet)
9. april 2022
Studiet fullført (Forventet)
9. april 2022
Datoer for studieregistrering
Først innsendt
12. juli 2018
Først innsendt som oppfylte QC-kriteriene
3. september 2018
Først lagt ut (Faktiske)
5. september 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. februar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. januar 2021
Sist bekreftet
1. januar 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P/2018/371
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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