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

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ClinicalTrials.gov Identifier: NCT03658005
Recruitment Status : Not yet recruiting
First Posted : September 5, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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

Condition or disease Intervention/treatment
Acute Coronary Syndrome Other: Blood sample

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Population-Based Pharmacokinetic / Pharmacodynamic Modeling of the Effect of Free Ticagrelor Fraction on the Platelet Membrane in Post Myocardial Infarction Patients
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Group/Cohort Intervention/treatment
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).

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).




Primary Outcome Measures :
  1. concentration of unbound ticagrelor and its metabolite [ Time Frame: 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

  2. concentration of unbound ticagrelor and its metabolite [ Time Frame: 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

  3. concentration of unbound ticagrelor and its metabolite [ Time Frame: 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


Secondary Outcome Measures :
  1. Assess the method of determination of ticagrelor concentration [ Time Frame: 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

  2. Assess the method of determination of ticagrelor concentration [ Time Frame: 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

  3. Assess the method of determination of ticagrelor concentration [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the Cardiology department with a main diagnosis of acute coronary syndrome and treated with a treatment combination including ticagrelor and aspirin.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658005


Contacts
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Contact: Jennifer Lagoutte-Renosi, MPharm +33370632379 jlagoutte@chu-besancon.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Nicolas Meneveau, MD, PhD Dept of Cardiology, CHU Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03658005     History of Changes
Other Study ID Numbers: P/2018/371
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Besancon:
Ticagrelor
acute coronary syndrome
anti-platelet drug

Additional relevant MeSH terms:
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Myocardial Ischemia
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs