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Mechanisms fo Clopidogrel Resistance in Older Adults (CEPAGE)

NCT04990596 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2026-03-31

No results posted yet for this study

Summary

A clopidogrel resistance rate of 40-50% has been found in the population over 70 years of age, whereas biological resistance, associated with an increased risk of cardiovascular events, is observed in about 20-30% of younger patients. One hypothesis is that the active metabolite is less available in resistant patients. Indeed, 85% of the absorbed clopidogrel undergoes inactivation by esterases. Then the remaining fraction undergoes two steps of metabolisation to the active thiol metabolite by CYP450, essentially the isoform 2C19. In older adults, increased esterase activity and/or decreased CYP450 2C19 activity may lead to a decreased concentration of the active metabolite. Multiple chronic conditions and polypharmacy encountered in older individuals are associated with basal platelet hyperactivity, and may also contribute to a poor response to clopidogrel. No data on the relationship between platelet response and circulating metabolite levels, or on the determinants of response to clopidogrel, are currently available in the geriatric population. Therefore, we propose to analyse the relationship between age and platelet and extra-platelet mechanisms potentially involved in the variability of response to clopidogrel.

Conditions

  • Drug Resistance

Interventions

BIOLOGICAL

additional blood sample

One sample per patient will be taken 1 to 3 hours after clopidogrel administration. Four additional tubes of 3 mL each will be collected for the study, for a total volume of 12 mL.

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Dominique SOMME, MD, Pr · CHU de Rennes - Service de Gériatrie

  • Isabelle GOUIN-THIBAULT, MD, PhD · CHU de Rennes - Service d'Hématologie Biologique

  • Eric PAUTAS, MD, Pr · Hôpital Charles Foix - Court séjour Gériatrique

  • Corinne FRERE, MD · CHU Pitié-Salpêtrière - Hématologie Biologique

  • Elena PAILLAUD, MD · Hôpital Européen Georges Pompidou, Service de Gériatrie Aiguë,

  • Pascale GAUSSEM, MD, Pr · Hôpital Européen Georges Pompidou - Service d'Hématologie Biologique,

  • Jean-Guillaume DILLINGER, MD · Hôpital Lariboisière - Service de Cardiologie

  • Virginie SIGURET, MD, Pr · Hôpital Lariboisière - Hématologie Biologique

Eligibility

Min Age
50 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2024-03-27
Completion
2025-01-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04990596 on ClinicalTrials.gov