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
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|
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 Type :||Observational|
|Actual Enrollment :||814446 participants|
|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|
First Initiators of VKA for non-valvular atrial fibrilation
First Initiators of Dabigatran for non-valvular atrial fibrilation
- 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
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
|University Hospital of Reunion Island|
|Saint Denis, Reunion Island, France, 97400|