- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03658005
Effect of Free Ticagrelor Fraction on Platelet Membrane Post MI (PLATIME)
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
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Jennifer Lagoutte-Renosi, MPharm
- Telefonnummer: +33370632379
- E-post: jlagoutte@chu-besancon.fr
Studieorter
-
-
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Besançon, Frankrike, 25000
- Rekrytering
- Chu Besancon
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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). |
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).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
concentration of unbound ticagrelor and its metabolite
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Assess the method of determination of ticagrelor concentration
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Nicolas Meneveau, MD, PhD, Dept of Cardiology, CHU Besancon
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P/2018/371
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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