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

Atrial Fibrillation Clinical Trial

— HELIOS-AF  

Official title:

Anticoagulant Treatment Patterns and Outcomes Among Non-valvular Atrial Fibrillation Patients With High Risk of Gastrointestinal Bleeding in France: a Retrospective Cohort Analysis Using SNDS Database

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05038228
• Other study ID #: B0661161
• Status: Active, not recruiting
• Start date: August 1, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Apixaban
Anticoagulant
• Rivaroxaban
Anticoagulant
• Dabigatran
Anticoagulant
• Vitamin K antagonist (VKA)
Anticoagulant

Locations

Country	Name	City	State
United Kingdom	Pfizer Investigator	London

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2016-2019
Primary	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.	2016-2019

External Links

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