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

NCT05038228 | Active Not Recruiting FDA Drug

• 2 other identifiers: B0661161NCT05038228
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Atrial Fibrillation

Keywords

Eliquis; Anti-Coagulation; Bleed; Stroke

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

NVAF High GI bleed risk

NVAF patients with a high risk of gastrointestinal bleeding

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

Interventions

Apixaban DRUG

Anticoagulant

NVAF High GI bleed risk

Vitamin K antagonist (VKA) DRUG

Anticoagulant

NVAF High GI bleed risk

Rivaroxaban DRUG

Anticoagulant

NVAF High GI bleed risk

Dabigatran DRUG

Anticoagulant

NVAF High GI bleed risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigator

London, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Atrial Fibrillation; Hemorrhage; Stroke

Interventions

apixaban; Rivaroxaban; Dabigatran; acarboxyprothrombin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 9, 2021
• Study Start: August 1, 2022
• Primary Completion: May 29, 2026
• Study Completion: May 29, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)