TRiptan Use and Serious Vascular Events in Elderly Over 65 Years

• Conditions: Migraine
• Interventions: Drug: Exposure to Triptan; Drug: Exposure to Ergot

• Registration Number: NCT02838537
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Status Verified: 2016-07
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-19
• Last Update Submitted: 2016-07-19
• Study First Posted: 2016-07-20
• Last Update Posted: 2016-07-20
• Primary Completion: 2016-12
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Triptan Arm	Exposure to Triptan	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")
Ergot Arm	Exposure to Ergot	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")

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	Assessment of the deaths, whatever the cause

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France