TRiptan Use and Serious Vascular Events in Elderly Over 65 Years

NCT02838537 | Unknown

• 1 other identifier: ANSM-RCAPHM13_0293
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

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

Keywords

Triptan; Drug utilization; Elderly; Drug abuse; Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Assessment of the mortality: number of all deaths

  Up to 4 years

• Assessment of the mortality with an underlying cardiovascular cause occuring in hospital

  Up to 4 years

Study Arms (2)

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")

Drug: 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")

Drug: Exposure to Ergot

Interventions

Exposure to Triptan DRUG

Triptan Arm

Exposure to Ergot DRUG

Ergot Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Both exposed cohorts will include all beneficiaries recorded in the SNIIR-AM aged 65 and older, who had an incident dispensation of any triptans (or ergot derivatives) over the study period. An incident dispensation is defined by the lack of dispensation for triptan (or ergot derivatives) for the first six months of the study period.

You may qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13005, France

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Substance-Related Disorders; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Catherine GEINDRE

  Assitance Publique - Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Joelle MICALLEF, MD-PhD

CONTACT

0491384642; joelle.micallef@ap-hm.fr

Kahena AMICHI

CONTACT

0491381966; kahena.amichi@ap-hm.fr

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 20, 2016
• Study Start: November 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

FR (1)