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TRiptan Use and Serious Vascular Events in Elderly Over 65 Years

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02838537
Acronym
TRUE
Enrollment
25000
Registered
2016-07-20
Start date
2015-11-30
Completion date
2017-05-31
Last updated
2016-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Triptan, Drug utilization, Elderly, Drug abuse, Cardiovascular disease

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 dInformation Inter-Régimes de lAssurance Maladie ; SNIIRAM) linked with the French hospital discharge database (Programme de Médicalisation des Systèmes dInformations, 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.

Interventions

DRUGExposure to Triptan
DRUGExposure to Ergot

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Occurence of the first vascular event leading to a hospitalization within the exposure period following the first dispensation of a triptan.Up to 4 years

Secondary

MeasureTime frameDescription
Assessment of the mortality: number of all deathsUp to 4 yearsAssessment of the deaths, whatever the cause
Assessment of the mortality with an underlying cardiovascular cause occuring in hospitalUp to 4 years

Countries

France

Contacts

Primary ContactJoelle MICALLEF, MD-PhD
joelle.micallef@ap-hm.fr0491384642
Backup ContactKahena AMICHI
kahena.amichi@ap-hm.fr0491381966

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026