TRiptan Use and Serious Vascular Events in Elderly Over 65 Years

Migraine Clinical Trial

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Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02838537
• Other study ID #: ANSM-RCAPHM13_0293
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2016
• Last updated: July 19, 2016
• Start date: November 2015
• Est. completion date: May 2017

Study information

• Verified date: July 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Joelle MICALLEF, MD-PhD
• Phone: 0491384642
• Email: joelle.micallef[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25000
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Migraine

Intervention

Drug:
• Exposure to Triptan

• Exposure to Ergot

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assessment of the mortality: number of all deaths	Assessment of the deaths, whatever the cause	Up to 4 years	No
Secondary	Assessment of the mortality with an underlying cardiovascular cause occuring in hospital		Up to 4 years	No