NCT03658005

Effect of Free Ticagrelor Fraction on Platelet Membrane Post MI

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
OTHER	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).

Timeline

• Start date: 2019-04-09
• Primary completion: 2022-04-09
• Completion: 2022-04-09
• First posted: 2018-09-05
• Last updated: 2021-02-02

Locations

1 site across 1 country: France