TRiptan Use and Serious Vascular Events in Elderly Over 65 Years (TRUE)

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.

Study Overview

• Status: Unknown
• Conditions: Migraine
• Intervention / Treatment: Drug: Exposure to Triptan; Drug: Exposure to Ergot

• Study Type: Observational
• Enrollment (Anticipated): 25000

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13005
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Contact: Joelle MICALLEF, MD-PhD; Phone Number: +33 0491384642; Email: joelle.micallef@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the mortality: number of all deaths	Assessment of the deaths, whatever the cause	Up to 4 years
Assessment of the mortality with an underlying cardiovascular cause occuring in hospital		Up to 4 years

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Catherine GEINDRE, Assitance Publique - Hôpitaux de Marseille

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Estimate): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 19, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Elderly; Cardiovascular disease; Drug abuse; Drug utilization; Triptan
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Serotonin 5-HT1 Receptor Agonists
• Other Study ID Numbers: ANSM-RCAPHM13_0293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED