Use of Public Health Surveillance Models in the French National Health System Database

Atrial Fibrillation Clinical Trial

— DABI-SURV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02904499
• Other study ID #: 2012/CHU/01
• Status: Completed
• Start date: December 2013
• Est. completion date: July 2018

Study information

• Verified date: September 2018
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 814446
• Est. completion date: July 2018
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients with non-valvular atrial fibrillation

• Patients receiving an first prescription of anticoagulants

Exclusion Criteria:

• Patients with valvular atrial fibrillation

Related Conditions & MeSH terms

• Anticoagulants
• Atrial Fibrillation
• Pharmacoepidemiology

Intervention

Drug:
• Dabigatran

Locations

Country	Name	City	State
France	University Hospital of Reunion Island	Saint Denis	Reunion Island

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	36 months