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

Sponsor

Centre Hospitalier Universitaire de la Réunion (Other)

Overall Status

Completed

CT.gov ID

NCT02904499

Collaborator

(none)

814,446

Enrollment

Location

Actual Duration (Months)

14817.5

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

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 :

Dec 1, 2013

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
VKA First Initiators of VKA for non-valvular atrial fibrilation
Dabigatran First Initiators of Dabigatran for non-valvular atrial fibrilation	Drug: Dabigatran

Arm

Intervention/Treatment

VKA

First Initiators of VKA for non-valvular atrial fibrilation

Dabigatran

First Initiators of Dabigatran for non-valvular atrial fibrilation

Drug: Dabigatran

Outcome Measures

Primary Outcome Measures

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 [36 months]
Propensity-matching is required for adequate comparison and multivariate regression

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Patients with valvular atrial fibrillation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Reunion Island	Saint Denis	Reunion Island	France	97400

Sponsors and Collaborators

Centre Hospitalier Universitaire de la Réunion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Laetitia HUIART, Methodologist, Centre Hospitalier Universitaire de la Réunion

ClinicalTrials.gov Identifier:

NCT02904499

Other Study ID Numbers:

2012/CHU/01

First Posted:

Sep 19, 2016

Last Update Posted:

Sep 5, 2018

Last Verified:

Sep 1, 2018

Keywords provided by Laetitia HUIART, Methodologist, Centre Hospitalier Universitaire de la Réunion

Atrial Fibrillation

Anticoagulants

Pharmacoepidemiology

Additional relevant MeSH terms:

Atrial Fibrillation

Dabigatran

Study Results

No Results Posted as of Sep 5, 2018