Skip to main content
Clinical Trials/NCT02838537
NCT02838537
Unknown
Not Applicable

TRiptan Use and Serious Vascular Events in Elderly Over 65 Years

Assistance Publique Hopitaux De Marseille1 site in 1 country25,000 target enrollmentNovember 2015

Overview

Phase
Not Applicable
Intervention
Exposure to Triptan
Conditions
Migraine
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
25000
Locations
1
Primary Endpoint
Occurence of the first vascular event leading to a hospitalization within the exposure period following the first dispensation of a triptan.
Last Updated
9 years ago

Overview

Brief Summary

This study will be conducted as a retrospective study of exposed and unexposed cohort of the French population included all beneficiaries aged 65 and older. Exposed patients will be matched to non exposed controls according age, gender and area of residence (ratio 1/4). Two exposed arms and two non exposed control arms will be planned. Triptan arm will be user of triptan defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months ("new or incident users"). Ergot arm will be user of ergot derivative defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months ("new or incident users"). This study involved data from the French National Health Insurance Information System (Système National d"Information Inter-Régimes de l"Assurance Maladie ; SNIIRAM) linked with the French hospital discharge database (Programme de Médicalisation des Systèmes d"Informations, PMSI).

  • The SNIIRAM is a vast national medico-administrative database representing the most part of the French population, allowing to identify and to describe precisely all medication dispensations (name of drug, date of dispensing and quantity) including triptans and other reimbursed medications.
  • The PMSI provides medical information about all patients admitted to hospital in France, including discharge diagnoses encoded according ICD-10, medical procedures and French diagnosis-related groups The research proposed is expected to provide an update and nationally-consolidated estimation of the cardiovascular risk is associated to triptans use in elderly population.
Registry
clinicaltrials.gov
Start Date
November 2015
End Date
May 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients aged 65 and more
  • Patients registered in the SNIIR-AM
  • To avoid depletion of susceptibles bias, only incident users will be included. Incident users are defined by the lack of reimbursement for triptan (or ergot derivatives) prior six months of the study period.

Exclusion Criteria

  • no exclusion criteria

Arms & Interventions

Triptan Arm

Users of triptan defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months ("new or incident users")

Intervention: Exposure to Triptan

Ergot Arm

Users of ergot derivative defined as at least one recorded dispensing of any drug during the follow up, with no recorded of any of these drugs during the previous 6 months ("new or incident users")

Intervention: Exposure to Ergot

Outcomes

Primary Outcomes

Occurence of the first vascular event leading to a hospitalization within the exposure period following the first dispensation of a triptan.

Time Frame: Up to 4 years

Secondary Outcomes

  • Assessment of the mortality with an underlying cardiovascular cause occuring in hospital(Up to 4 years)
  • Assessment of the mortality: number of all deaths(Up to 4 years)

Study Sites (1)

Loading locations...

Similar Trials