High Gastrointestinal Bleed Risk Outcomes in Patients With Non-valvular Atrial Fibrillation (NVAF) in France

N/AActive Not RecruitingNCT05038228

Pfizer1 enrolled

Overview

This study is a retrospective analysis of observational cohorts using data from prospectively collected administrative/claims data to investigate treatment patterns, and safety and effectiveness outcomes in patients with NVAF with high risk of gastrointestinal bleed who initiate anticoagulant treatment with a Vitamin-K Antagonists (VKAs) or direct-acting oral anticoagulants (DOACs).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Atrial Fibrillation

Interventions

ApixabanDRUG

Anticoagulant

RivaroxabanDRUG

Anticoagulant

DabigatranDRUG

Anticoagulant

Vitamin K antagonist (VKA)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients covered by the French national health insurance general scheme With at least one reimbursement of AC treatment (apixaban, rivaroxaban, dabigatran, or VKAs) Aged ≥18 years as of the index date With a diagnosis of atrial fibrillation (AF) prior to or on the index date With at least one risk factor for gastrointestinal bleeding Exclusion Criteria: Patients with different types of AC treatment at the index date Patients with a diagnosis or procedure code indicative of rheumatic mitral valvular heart disease or valve replacement procedure Individuals with a diagnosis of VTE during the 12 months prior to or on the index date

Locations (1)

Pfizer Investigator

London, United Kingdom

Outcomes

Primary Outcomes

Bleeding leading to hospitalization

The follow-up period will be from the index date to death or end of study (31 December 2019). For the comparative analyses of clinical outcomes the follow-up period will be from the day after index date to the earliest of an outcome of interest (separately for each outcome); treatment discontinuation, treatment switch, death, or end of study.

Time frame: 2016-2019

Stroke

The follow-up period will be from the index date to death or end of study (31 December 2019). For the comparative analyses of clinical outcomes the follow-up period will be from the index date to the earliest of an outcome of interest (separately for each outcome); treatment discontinuation, treatment switch, death, or end of study.

Time frame: 2016-2019

Data from ClinicalTrials.gov

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