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

Pfizer

Status: Active, not recruiting

Conditions: Atrial Fibrillation

Treatments: Drug: Apixaban; Drug: Rivaroxaban; Drug: Dabigatran; Drug: Vitamin K antagonist (VKA)

Study type: Observational

Funder types: Industry

Identifiers

NCT05038228

B0661161

NCT05038228 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1 participants in 1 patient group

NVAF High GI bleed risk

Description:

NVAF patients with a high risk of gastrointestinal bleeding

Treatment:

Drug: Vitamin K antagonist (VKA)

Drug: Dabigatran

Drug: Rivaroxaban

Drug: Apixaban