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

NCT ID: NCT05038228

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2026-04-08

Brief Summary

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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).

Detailed Description

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Conditions

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Atrial Fibrillation

Keywords

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Eliquis Anti-Coagulation Bleed Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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NVAF High GI bleed risk

NVAF patients with a high risk of gastrointestinal bleeding

Apixaban

Intervention Type DRUG

Anticoagulant

Rivaroxaban

Intervention Type DRUG

Anticoagulant

Dabigatran

Intervention Type DRUG

Anticoagulant

Vitamin K antagonist (VKA)

Intervention Type DRUG

Anticoagulant

Interventions

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Apixaban

Anticoagulant

Intervention Type DRUG

Rivaroxaban

Anticoagulant

Intervention Type DRUG

Dabigatran

Anticoagulant

Intervention Type DRUG

Vitamin K antagonist (VKA)

Anticoagulant

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigator

London, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B0661161

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

Other Identifiers

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NCT05038228

Identifier Type: REGISTRY

Identifier Source: secondary_id

B0661161

Identifier Type: -

Identifier Source: org_study_id