MigraineTRUENCT02838537
TRiptan Use and Serious Vascular Events in Elderly Over 65 Years
An observational study of Migraine, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Exposure to Triptan and Exposure to Ergot
- How many people
- 25,000 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13005
Joelle MICALLEF, MD-PhD, 0491384642 ext. +33, joelle.micallef@ap-hm.fr
About this study
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
- Being tested
- Exposure to Triptan, Exposure to Ergot
- Keywords
- Triptan, Drug utilization, Elderly, Drug abuse, Cardiovascular disease
- Medical subject headings
- Migraine Disorders, Substance-Related Disorders, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to TriptanDrug
Exposure to ErgotDrug
| Study group | Role | What they receive |
|---|---|---|
| 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") Receives: 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") Receives: Drug: Exposure to Ergot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of the first vascular event leading to a hospitalization within the exposure period following the first dispensation of a triptan.
Measured: Up to 4 years
Secondary outcomes (2)
Assessment of the mortality: number of all deaths
Assessment of the deaths, whatever the cause
Measured: Up to 4 years
Assessment of the mortality with an underlying cardiovascular cause occuring in hospital
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine GEINDRE, Study director, Assitance Publique - Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838537
- Sponsor's protocol ID
- ANSM-RCAPHM13_0293
- Acronym
- TRUE
- Status last verified
- Jul 2016
- First submitted
- 18 Jul 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRiptan Use and Serious Vascular Events in Elderly Over 65 Years
- ClinicalTrials.gov ID
- NCT02838537
- Acronym / sponsor ID
- TRUE / ANSM-RCAPHM13_0293
- Conditions
- Migraine
- Keywords
- Triptan, Drug utilization, Elderly, Drug abuse, Cardiovascular disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triptan Arm | – | Drug: Exposure to TriptanUsers 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 | – | Drug: Exposure to ErgotUsers 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") |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure to Triptan | Drug | Triptan Arm |
| Exposure to Ergot | Drug | Ergot Arm |
Primary outcome
Occurence of the first vascular event leading to a hospitalization within the exposure period following the first dispensation of a triptan.
Time frame: Up to 4 years
2 secondary outcomes
Assessment of the mortality: number of all deaths
Time frame: Up to 4 years
Assessment of the mortality with an underlying cardiovascular cause occuring in hospital
Time frame: Up to 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine GEINDRE study director
Assitance Publique - Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joelle MICALLEF, MD-PhD (0491384642 ext. +33, joelle.micallef@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of the first vascular event leading to a hospitalization within the exposure period following the first dispensation of a triptan. (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.