TRiptan Use and Serious Vascular Events in Elderly Over 65 Years

NCT ID: NCT02838537

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 25000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-05-31

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.

Conditions

Migraine

Study Design

• Study Time Perspective: RETROSPECTIVE

Study Groups

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")

Exposure to Triptan

Intervention Type: DRUG

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")

Exposure to Ergot

Intervention Type: DRUG

Interventions

Exposure to Triptan

Intervention Type: DRUG

Exposure to Ergot

Intervention Type: DRUG

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine GEINDRE

Role: STUDY_DIRECTOR

Assitance Publique - Hôpitaux de Marseille

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Joelle MICALLEF, MD-PhD

Role: CONTACT

joelle.micallef@ap-hm.fr

0491384642 ext. +33

Kahena AMICHI

Role: CONTACT

kahena.amichi@ap-hm.fr

0491381966 ext. +33

Facility Contacts

Joelle MICALLEF, MD-PhD

Role: primary

joelle.micallef@ap-hm.fr

0491384642 ext. +33

Other Identifiers

ANSM-RCAPHM13_0293

Identifier Type: -

Identifier Source: org_study_id