Status: Ongoing First registered on: 19/03/2015
Last updated on: 20/12/2018
1. Study identification
EU PAS Register NumberEUPAS8976
Official titleTRiptan Use and serious vascular events in Elderly over 65 years
Study title acronymTRUE
Study typeObservational study
Brief description of the studyTriptans have improved the quality of life of acute migraine by providing a higher degree of efficacy and a more favorable side effect profile than ergotamine. Even though triptan are not recommended in older patients (over 65 years), some utilization studies show that older patients account for 5% to 10% of triptan users. To our knowledge, no specific vascular safety study has been performed among older patients exposed to triptan. The main objective of TRUE study is to compare the incidence of cardiovascular events between a population of older (age > 65 years) triptan users and a control population. The study design is a French comparative retrospective cohort study (exposed cohort vs. unexposed cohort). We will use data from the French National Health Insurance information system (SNIIRAM) linked with the French Hospital discharge database (PMSI). We will include patients aged over 65 years, who are registered in SNIIRAM. For the exposed cohort, we will only include incident users of triptans. Exposed and unexposed cohorts will be matched (1:4 ratio) according to age, gender and area of residence. The events of interest are i) cardio-vascular events, ii) death from all causes and death related to a cario-vascular event Data will be analyzed using Cox proportional hazards models, taking into account confounders.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUPCET
Department/Research groupPharmacology Department
Organisation/affiliationUPCET
Website/Homepage
Details of (Primary) lead investigator
Title Dr
Last name MICALLEF
First name Joelle
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

Pharmacoepidemiology INSERM 1027
Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/10/2013
Start date of data collection01/06/201501/11/2015
Start date of data analysis10/01/2016
Date of interim report, if expected20/12/2017
Date of final study report01/09/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyAgence Nationale de Sécurité du Médicament et des produits de santé (ANSM)100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name MICALLEF
First name Joelle
Address line 1Timone University Hospital, 254 Rue saint Pierre, 13385
Address line 2 
Address line 3 
CityMarseille 
Postcode13385 
CountryFrance
Phone number (incl. country code)33491387563 
Alternative phone number 
Fax number (incl. country code) 
Email address joelle.micallef@ap-hm.fr
Public Enquiries
Title Dr 
Last name MICALLEF 
First name Joelle 
Address line 1Timone University Hospital, 254 Rue saint Pierre, 13385 
Address line 2 
Address line 3 
CityMarseille 
Postcode13385 
CountryFrance 
Phone number (incl. country code)33491387563 
Alternative phone number 
Fax number (incl. country code) 
Email address joelle.micallef@ap-hm.fr 
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