NCT03658005

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

April 9, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2022

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

July 12, 2018

Last Update Submit

January 29, 2021

Conditions

Acute Coronary Syndrome

Keywords

Ticagreloracute coronary syndromeanti-platelet drug

Outcome Measures

Primary Outcomes (3)

  • concentration of unbound ticagrelor and its metabolite

    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

    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

    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

Secondary Outcomes (3)

  • Assess the method of determination of ticagrelor concentration

    at 3 hours after administration of the first dose of ticagrelor

  • Assess the method of determination of ticagrelor concentration

    at 6 hours after administration of the first dose of ticagrelor

  • Assess the method of determination of ticagrelor concentration

    at 12 hours after administration of the first dose of ticagrelor

Study Arms (1)

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

Interventions

Blood sampleOTHER

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).

Study cohort

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Nicolas Meneveau, MD, PhD

    Dept of Cardiology, CHU Besancon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Lagoutte-Renosi, MPharm

CONTACT

+33370632379jlagoutte@chu-besancon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2018

First Posted

September 5, 2018

Study Start

April 9, 2019

Primary Completion

April 9, 2022

Study Completion

April 9, 2022

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)