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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

NCT ID: NCT05838664

Last Updated: 2025-12-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2140403 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-07

Study Completion Date

2024-09-30

Brief Summary

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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

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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AF patients unexposed to oral anticoagulants

No OAC

Intervention Type DRUG

AF Patient who were not exposed to oral anticoagulation

AF patients exposed to VKA

VKA

Intervention Type DRUG

AF patients who received VKA

AF patients exposed to apixaban

apixaban

Intervention Type DRUG

AF patients who received apixaban

AF patients exposed to rivaroxaban

rivaroxaban

Intervention Type DRUG

AF patients who received rivaroxaban

AF patients exposed to dabigatran

dabigatran

Intervention Type DRUG

AF patients who received dabigatran

Interventions

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No OAC

AF Patient who were not exposed to oral anticoagulation

Intervention Type DRUG

VKA

AF patients who received VKA

Intervention Type DRUG

apixaban

AF patients who received apixaban

Intervention Type DRUG

rivaroxaban

AF patients who received rivaroxaban

Intervention Type DRUG

dabigatran

AF patients who received dabigatran

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Paris, , France

Site Status

Countries

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France

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B0661173

To obtain contact information for a study center near you, click here.

Other Identifiers

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SIFNOS

Identifier Type: OTHER

Identifier Source: secondary_id

B0661173

Identifier Type: -

Identifier Source: org_study_id