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

Atrial Fibrillation Clinical Trial

— BROTHER  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864758
• Other study ID #: 18656
• Status: Completed
• Start date: September 8, 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: November 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99999
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY59-7939)
Tablets, 20mg once daily
• Vitamin K antagonists
Tablets, dose is based on International Normalized Ratio
• dabigatran (Pradaxa)
Tablets, 150 mg twice daily

Locations

Country	Name	City	State
France	Many Locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

France, 

References & Publications (1)

Blin P, Fauchier L, Dureau-Pournin C, Sacher F, Dallongeville J, Bernard MA, Lassalle R, Droz-Perroteau C, Moore N. Effectiveness and Safety of Rivaroxaban 15 or 20 mg Versus Vitamin K Antagonists in Nonvalvular Atrial Fibrillation. Stroke. 2019 Sep;50(9):2469-2476. doi: 10.1161/STROKEAHA.119.025824. Epub 2019 Aug 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year and Two Year
Primary	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.	One year and Two Year
Primary	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.	One year and Two Year
Secondary	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	Up to two years
Secondary	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	One year and Two Year
Secondary	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	Up to two years
Secondary	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)	Up to two years
Secondary	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)	Up to two years

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