Effect of Free Ticagrelor Fraction on Platelet Membrane Post MI

NCT ID: NCT03658005

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-09
• Study Completion Date: 2022-04-09

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Blood sample

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Meneveau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Cardiology, CHU Besancon

Locations

CHU Besançon

Besançon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Jennifer Lagoutte-Renosi, MPharm

Role: CONTACT

jlagoutte@chu-besancon.fr

+33370632379

Facility Contacts

ELISE ROBERT

Role: primary

e1robert@chu-besancon.fr

0381219086

Other Identifiers

P/2018/371

Identifier Type: -

Identifier Source: org_study_id