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Use of Public Health Surveillance Models in the French National Health System Database (DABI-SURV)

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ClinicalTrials.gov Identifier: NCT02904499
Recruitment Status : Completed
First Posted : September 19, 2016
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Laetitia HUIART, Centre Hospitalier Universitaire de la Réunion

Brief 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. 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.


Condition or disease Intervention/treatment
Atrial Fibrillation Anticoagulants Pharmacoepidemiology Drug: Dabigatran

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.


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Study Type : Observational
Actual Enrollment : 814446 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : December 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : July 2018


Group/Cohort Intervention/treatment
VKA
First Initiators of VKA for non-valvular atrial fibrilation
Dabigatran
First Initiators of Dabigatran for non-valvular atrial fibrilation
Drug: Dabigatran



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • Patients with non-valvular atrial fibrillation
  • Patients receiving an first prescription of anticoagulants

Exclusion Criteria:

  • Patients with valvular atrial fibrillation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904499


Locations
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France
University Hospital of Reunion Island
Saint Denis, Reunion Island, France, 97400
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion

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Responsible Party: Laetitia HUIART, Methodologist, Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT02904499     History of Changes
Other Study ID Numbers: 2012/CHU/01
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Keywords provided by Laetitia HUIART, Centre Hospitalier Universitaire de la Réunion:
Atrial Fibrillation
Anticoagulants
Pharmacoepidemiology
Additional relevant MeSH terms:
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Dabigatran
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants