Trial Condition(s):
Atrial Fibrillation
Benefit-Risk Of arterial THrombotic prEvention with Rivaroxaban for atrial fibrillation in France (BROTHER)
Bayer Identifier:
18656
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, France | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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:
3
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.Timeframe: One year and Two Year
- Major BleedingHospitalization 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.Timeframe: One year and Two Year
- DeathAll-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.Timeframe: One year and Two Year
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 useTimeframe: Up to two years
- A composite of stroke and SE, major bleeding and death, clinically relevant bleeding and acute coronary syndromeTo compare one year and two year risk between new users of anticoagulant for SPAF during drug exposure: rivaroxaban vs VKA, and rivaroxaban vs dabigatranTimeframe: 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 outcomesDuring drug exposure for rivaroxaban, dabigatran, and VKATimeframe: 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 outcomesPost-anticoagulant exposure for rivaroxaban, dabigatran, and VKA (i.e. after anticoagulant discontinuation)Timeframe: Up to two years
- Healthcare resources utilisationHealthcare 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)Timeframe: Up to two years
Additional Information
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