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TRiptan Use and Serious Vascular Events in Elderly Over 65 Years

NCT02838537 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 25000

Last updated 2016-07-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Exposure to Triptan

DRUG

Exposure to Ergot

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Catherine GEINDRE · Assitance Publique - Hôpitaux de Marseille

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-12-31
Completion
2017-05-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT02838537 on ClinicalTrials.gov