Atrial FibrillationDABI-SURVNCT02904499
Use of Public Health Surveillance Models in the French National Health System Database
An observational study of Atrial Fibrillation and Anticoagulants, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
Public health surveillance models, previously used for the ongoing detection of occurrence of rare events, could be used to reinforce existing pharmacovigilance systems. These models have not been previously used for Adverse Drug Reaction (ADR) detection in medico-administrative databases. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation, Anticoagulants, Pharmacoepidemiology
- What is being tested?
- Dabigatran
- How many people
- 814,446 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Jul 2018
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of adult patients diagnosed with AF or atrial flutter and who received at least one prescription of VKA (warfarin /acenocoumarol /fluindion) or dabigatran between 2009 and 2014. As opposed to other countries, in France, warfarin is not the most prescribed VKA for AF.
Who may be able to join
- Patients with non-valvular atrial fibrillation
- Patients receiving an first prescription of anticoagulants
Who cannot join
- Patients with valvular atrial fibrillation
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Reunion Island
Saint-Denis, Reunion Island, 97400
About this study
Official title: Use of Public Health Surveillance Models in the French National Health System Database: A Tool for an Ongoing Monitoring of Adverse Drug Reaction? The Case of Dabigatran
Public health surveillance models, previously used for the ongoing detection of occurrence of rare events, could be used to reinforce existing pharmacovigilance systems. These models have not been previously used for Adverse Drug Reaction (ADR) detection in medico-administrative databases. DABISURV research project focuses on a new anticoagulant therapy, dabigatran, launched recently on the French market for atrial fibrillation (AF). This drug is at high risk for severe ADR and requires thus careful pharmacovigilance monitoring.
Primary objective is to compare the results of ongoing surveillance models to detect hemorrhages or acute myocardial infarction (AMI) associated with dabigatran, with the results obtained from the analysis of a cohort of patients with AF under the same treatment.
Read the detailed description
DABISURV study consists in an analyze of a cohort of patients with AF who have received at least one prescription Vitamin K Antagonists (VKA) - reference group - or of dabigatran in the French National Health Insurance System.
The uptake of dabigatran is followed for detecting hemorrhagic events or AMI associated with this molecule among first users.
The ability to detect quickly substantial ADR of new drugs is of critical importance to public health in order to facilitate timely public health response. If the public health surveillance models are found useful for this topic, then semi-automated procedures would be needed to detect ADR associated with new generation anticoagulants in medico-administrative databases. If the public health surveillance models are found not useful for the detection of ADR, the cohort study itself will provide essential data on the safety profile of dabigatran.
- Conditions
- Atrial Fibrillation, Anticoagulants, Pharmacoepidemiology
- Being tested
- Dabigatran
- Keywords
- Atrial Fibrillation, Anticoagulants, Pharmacoepidemiology
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabigatranDrug
| Study group | Role | What they receive |
|---|---|---|
| VKA | First Initiators of VKA for non-valvular atrial fibrilation | |
| Dabigatran | First Initiators of Dabigatran for non-valvular atrial fibrilation Receives: Drug: Dabigatran |
What is being measured
The primary outcome is the main question the study is designed to answer.
results of ongoing surveillance models to detect hemorrhages or AMI (in frequency and proportion) associated with dabigatran or VKA for AF in a health database cohort of patients with AF treated by dabigatran or VKA
Propensity-matching is required for adequate comparison and multivariate regression
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startDec 2013
- Primary completionSep 2016
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 814,446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laetitia HUIART, Centre Hospitalier Universitaire de la Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904499
- Sponsor's protocol ID
- 2012/CHU/01
- Acronym
- DABI-SURV
- Status last verified
- Sep 2018
- First submitted
- 9 Sep 2016
- Last updated
- 5 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Public Health Surveillance Models in the French National Health System Database: A Tool for an Ongoing Monitoring of Adverse Drug Reaction? The Case of Dabigatran
- ClinicalTrials.gov ID
- NCT02904499
- Acronym / sponsor ID
- DABI-SURV / 2012/CHU/01
- Conditions
- Atrial Fibrillation, Anticoagulants, Pharmacoepidemiology
- Keywords
- Atrial Fibrillation, Anticoagulants, Pharmacoepidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 814,446 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 19 Sep 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.
Public health surveillance models, previously used for the ongoing detection of occurrence of rare events, could be used to reinforce existing pharmacovigilance systems. These models have not been previously used for Adverse Drug Reaction (ADR) detection in medico-administrative databases. DABISURV research project focuses on a new anticoagulant therapy, dabigatran, launched recently on the French market for atrial fibrillation (AF). This drug is at high risk for severe ADR and requires thus careful pharmacovigilance monitoring.
Primary objective is to compare the results of ongoing surveillance models to detect hemorrhages or acute myocardial infarction (AMI) associated with dabigatran, with the results obtained from the analysis of a cohort of patients with AF under the same treatment.
Detailed description
DABISURV study consists in an analyze of a cohort of patients with AF who have received at least one prescription Vitamin K Antagonists (VKA) - reference group - or of dabigatran in the French National Health Insurance System.
The uptake of dabigatran is followed for detecting hemorrhagic events or AMI associated with this molecule among first users.
The ability to detect quickly substantial ADR of new drugs is of critical importance to public health in order to facilitate timely public health response. If the public health surveillance models are found useful for this topic, then semi-automated procedures would be needed to detect ADR associated with new generation anticoagulants in medico-administrative databases. If the public health surveillance models are found not useful for the detection of ADR, the cohort study itself will provide essential data on the safety profile of dabigatran.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VKA | – | –First Initiators of VKA for non-valvular atrial fibrilation |
| Dabigatran | – | Drug: DabigatranFirst Initiators of Dabigatran for non-valvular atrial fibrilation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of adult patients diagnosed with AF or atrial flutter and who received at least one prescription of VKA (warfarin /acenocoumarol /fluindion) or dabigatran between 2009 and 2014. As opposed to other countries, in France, warfarin is not the most prescribed VKA for AF.
Key inclusion criteria (2 listed)
- Patients with non-valvular atrial fibrillation
- Patients receiving an first prescription of anticoagulants
Key exclusion criteria (1 listed)
- Patients with valvular atrial fibrillation
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 |
|---|---|---|
| Dabigatran | Drug | Dabigatran |
Primary outcome
results of ongoing surveillance models to detect hemorrhages or AMI (in frequency and proportion) associated with dabigatran or VKA for AF in a health database cohort of patients with AF treated by dabigatran or VKA
Time frame: 36 months
Propensity-matching is required for adequate comparison and multivariate regression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Atrial Fibrillation and Anticoagulants, run by Centre Hospitalier Universitaire de la Réunion 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 5 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
results of ongoing surveillance models to detect hemorrhages or AMI (in frequency and proportion) associated with dabigatran or VKA for AF in a health database cohort of patients with AF treated by dabigatran or VKA (time frame: 36 months). 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 5 Sep 2018.