Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France (BROTHER)

November 5, 2023 updated by: Bayer

Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in Daily Clinical Practice - A French Cohort Within the Nationwide Claims and Hospital Database

The purpose of the study is to compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for Stroke prevention in atrial fibrillation (SPAF) during drug exposure: rivaroxaban versus Vitamin K antagonists (VKA), and rivaroxaban versus dabigatran

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Main objective: To compare the one-year and two-year risk of each of the following individual outcomes: Stroke and systemic embolism (SE), major bleeding and death between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran.

Secondary objectives:

  • To describe the drug exposure to rivaroxaban, dabigatran, and VKA for SPAF in new users, as well as and pattern of use;
  • To compare the one-year and two-year risk of the following individual outcomes: a composite of stroke and SE, major bleeding and death, clinically relevant bleeding (CRB) and acute coronary syndrome (ACS) between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran;
  • To estimate the cumulative incidence and the incidence rate of each individual main and secondary outcome (stroke and SE, major bleeding, CRB, death, composite criteria, and ACS), as well as according to individual diagnose of each of these outcomes, during drug exposure for rivaroxaban, dabigatran, and VKA;
  • To estimate the cumulative incidence of each individual main and secondary outcome (stroke and SE, major bleeding, CRB, death, composite criteria, and ACS), as well as according individual diagnose of each of these outcomes during post-anticoagulant exposure for rivaroxaban, dabigatran, and VKA (i.e. after anticoagulant discontinuation);
  • To assess outcome risk factors, including (but not limited to), gender, age, stroke and bleeding risk scores (CHA2DS2-VASc and HAS-BLED), low or high dosage at index date for DOAC, drug predisposing to bleeding during drug exposure and significant baseline characteristics;
  • To describe and compare healthcare resources utilisation related to SPAF during rivaroxaban, dabigatran, and VKA exposure, including outcomes, and their related costs from the societal perspective and from the French healthcare insurance perspective.

Study Type

Observational

Enrollment (Actual)

99999

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Multiple Locations, France
        • Many locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All subjects with a first reimbursed dispensation of rivaroxaban (15 or 20 mg), dabigatran (110 or 150 mg) or vitamin k antagonists in 2013 or 2014 diagnosed with Atrial Fibrillation

Description

Inclusion Criteria:

  • Definite non-valvular atrial fibrillation:
  • A first reimbursed dispensation of rivaroxaban, dabigatran, or VKA in 2013 or 2014, and
  • No previous DOAC (rivaroxaban, dabigatran, apixaban) or VKA dispensation during the previous three years,
  • Definite AF information in the database Probable non-valvular atrial fibrillation:-
  • A first reimbursed dispensation of rivaroxaban, dabigatran, or VKA in 2013 or 2014, and
  • No previous DOAC (rivaroxaban, dabigatran, apixaban) or VKA dispensation during the previous three years,
  • Probable AF information in the database (using the development of an AF disease score, see variables definition below),

Exclusion Criteria:

  • Patients with Rheumatic valve disease
  • Patients with valve replacement
  • Patients treated with anticoagulants for venous
  • thromboemboslim or prevention of venous
  • thromboembolism after orthopedic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Adult patients with nonvalvular atrial fibrillation (NVAF) treated with rivaroxaban
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Tablets, 20mg once daily
Group 2
Adult patients with nonvalvular atrial fibrillation (NVAF) treated with vitamin k anatognists
Drug: Vitamin K antagonists
Tablets, dose is based on International Normalized Ratio
Group 3
Adult patients with nonvalvular atrial fibrillation (NVAF) treated with dabigatran
Drug: dabigatran (Pradaxa)
Tablets, 150 mg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke and systemic embolism (Effectiveness outcome)
Time Frame: One year and Two Year
Hospitalization with ischemic or undefined stroke or other systemic arterial embolism or surgical procedure for systemic arterial embolism To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran.
One year and Two Year
Major Bleeding
Time Frame: One year and Two Year

Hospitalization with haemorrhagic stroke, other critical organ or site bleeding (intraspinal, intraocular,retroperitoneal, intraarticular or pericardial, or intramuscular), Other bleeding with a transfusion during hospital stay, or resulting in death.

To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran.
One year and Two Year
Death
Time Frame: One year and Two Year
All-cause death. To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran.
One year and Two Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of use (Exposure, Adherence, Discontinuation, Switch)
Time Frame: Up to two years
To describe the drug exposure to rivaroxaban, dabigatran, and VKA for SPAF in new users and pattern of use
Up to two years
A composite of stroke and SE, major bleeding and death, clinically relevant bleeding and acute coronary syndrome
Time Frame: One year and Two Year
To compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban vs VKA, and rivaroxaban vs dabigatran
One year and Two Year
Cumulative incidence and incidence rate of stroke and SE, major bleeding, clinically relevant bleeding, death, composite criteria, and acute coronary syndrome as well as according individual diagnose of each of these outcomes
Time Frame: Up to two years
During drug exposure for rivaroxaban, dabigatran, and VKA
Up to two years
Cumulative incidence of Stroke and SE, major bleeding, clinically relevant bleeding, death, composite criteria, and acute coronary syndrome as well as according individual diagnose of each of these outcomes
Time Frame: Up to two years
Post-anticoagulant exposure for rivaroxaban, dabigatran, and VKA (i.e. after anticoagulant discontinuation)
Up to two years
Healthcare resources utilisation
Time Frame: Up to two years
Healthcare resources use will be described from reimbursed claims and hospitalisation information Healthcare resources cost will be estimated using the French HAS methodological guide for economic evaluations (2011)
Up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Scientific Affairs, LLC

Investigators

  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2016

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimated)

August 12, 2016

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18656

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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