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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Apixaban; Drug: Rivaroxaban; Drug: Dabigatran; Drug: Vitamin K antagonist (VKA)

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Pfizer Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a diagnosis of non-valvular atrial fibrillation being treated with anticoagulation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NVAF High GI bleed risk; NVAF patients with a high risk of gastrointestinal bleeding	Drug: Apixaban; Anticoagulant; Drug: Rivaroxaban; Anticoagulant; Drug: Dabigatran; Anticoagulant; Drug: Vitamin K antagonist (VKA); Anticoagulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): May 29, 2026

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Eliquis; Anti-Coagulation; Bleed
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Stroke; Atrial Fibrillation; Hemorrhage; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Morpholines; Oxazines; Thiophenes; Rivaroxaban; Dabigatran; apixaban; acarboxyprothrombin
• Other Study ID Numbers: B0661161; NCT05038228 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No