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Completed

NCT Number: NCT02864758

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

2 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

Tablets, 20mg once daily

Vitamin K antagonists

Drug

Tablets, dose is based on International Normalized Ratio

Dabigatran (Pradaxa)

Drug

Tablets, 150 mg twice daily

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Scientific Affairs, LLC

Registry information

Official study title

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

Acronym: BROTHER

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 12, 2016
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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