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

NCT02904499 | Completed

• 1 other identifier: 2012/CHU/01
• Study Type: observational
• Target: 814,446
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Anticoagulants; Pharmacoepidemiology

Keywords

Atrial Fibrillation; Anticoagulants; Pharmacoepidemiology

Outcome Measures

Primary Outcomes (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

  Propensity-matching is required for adequate comparison and multivariate regression

  36 months

Study Arms (2)

VKA

First Initiators of VKA for non-valvular atrial fibrilation

Dabigatran

First Initiators of Dabigatran for non-valvular atrial fibrilation

Drug: Dabigatran

Interventions

Dabigatran DRUG

Dabigatran

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients with valvular atrial fibrillation

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

University Hospital of Reunion Island

Saint-Denis, Reunion Island, 97400, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Methodologist

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 19, 2016
• Study Start: December 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: July 1, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

FR (1)