A Study to Learn About the Effects of Medicines That Help in Thinning the Blood in People With Atrial Fibrillation (AF) Between 2016 and 2020 in France

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: rivaroxaban; Drug: dabigatran; Drug: VKA; Drug: No OAC; Drug: apixaban

• Registration Number: NCT05838664
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to look at how many patients with AF had strokes, major bleeding and death in both people who had and had not taken any oral anticoagulant. Atrial fibrillation (AF) is an irregular and often very rapid heart rhythm (arrhythmia) that can lead to blood clots in the heart.

This increases the risk of stroke. Anticoagulants are medicines, also called blood thinners, which help prevent blood clots from forming or getting bigger.

This study includes patient's data from the database who:

* Had at least one hospital stay with AF

* Are new users of OACs for AF treatment

* Are 18 years and older when they were confirmed to have AF All the patient's data included in this study would have either received the OAC therapy or not.

This study aims to look at any events of strokes, major bleeding and death. The data of patients will be collected from the French national health insurance claims database (SNDS). The planned study period is thought to be from 1st January 2016 till 31st December 2020

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-01
• Study Start: 2023-07-07
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3691397

Inclusion Criteria

• Identified patients with AF aged 18 years and older at diagnosis of AF

Exclusion Criteria

• AF Patients with at least one hospital stays for associated valve disease or valve surgery
• Patients treated with an OAC for another indication than AF

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AF patients exposed to rivaroxaban	rivaroxaban	-
AF patients exposed to dabigatran	dabigatran	-
AF patients exposed to VKA	VKA	-
AF patients unexposed to oral anticoagulants	No OAC	-
AF patients exposed to apixaban	apixaban	-

Primary Outcome Measures

Name	Time	Method
clinical outcome in participants	up to 5 years	incidence rate of stroke, major bleeding, and death in both non-valvular AF patients exposed to OAC (VKA or DOAC) and unexposed to OAC

Secondary Outcome Measures

Name	Time	Method
clinical outcome in participants	up to 5 years	Comparison of HCRU and associated costs

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇫🇷 Paris, France