check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

18656

ClinicalTrials.gov Identifier:

NCT02864758

EudraCT Number:

Not Available

EU CT Number:

Not Available
Benefit-Risk Of arterial THrombotic prEvention with Rivaroxaban for atrial fibrillation in France

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

2 - 99 Years
  • - 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),


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

Trial summary

Enrollment Goal
99999
Trial Dates
September 2016 - September 2018
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, France

Primary Outcome

  • Stroke and systemic embolism (Effectiveness outcome)
    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.
    date_rangeTime Frame:
    One year and Two Year
    enhanced_encryption
    Safety Issue:
    No
  • Major Bleeding
    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.
    date_rangeTime Frame:
    One year and Two Year
    enhanced_encryption
    Safety Issue:
    Yes
  • Death
    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.
    date_rangeTime Frame:
    One year and Two Year
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Pattern of use (Exposure, Adherence, Discontinuation, Switch)
    To describe the drug exposure to rivaroxaban, dabigatran, and VKA for SPAF in new users and pattern of use
    date_rangeTime Frame:
    Up to two years
    enhanced_encryption
    Safety Issue:
    No
  • A composite of stroke and SE, major bleeding and death, clinically relevant bleeding and acute coronary syndrome
    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
    date_rangeTime Frame:
    One year and Two Year
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    During drug exposure for rivaroxaban, dabigatran, and VKA
    date_rangeTime Frame:
    Up to two years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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
    Post-anticoagulant exposure for rivaroxaban, dabigatran, and VKA (i.e. after anticoagulant discontinuation)
    date_rangeTime Frame:
    Up to two years
    enhanced_encryption
    Safety Issue:
    Yes
  • Healthcare resources utilisation
    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)
    date_rangeTime Frame:
    Up to two years
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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