Clinical trial NCT02864758: Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2016-08-12
Enrollment: 99999
Sex: ALL
Minimum age (years): 2
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stroke and systemic embolism (Effectiveness outcome)
timeFrame: One year and Two Year
measure: Major Bleeding
timeFrame: One year and Two Year
measure: Death
timeFrame: One year and Two Year
Secondary outcomes:
measure: Pattern of use (Exposure, Adherence, Discontinuation, Switch)
timeFrame: Up to two years
measure: A composite of stroke and SE, major bleeding and death, clinically relevant bleeding and acute coronary syndrome
timeFrame: One year and Two Year
measure: 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
timeFrame: Up to two years
measure: 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
timeFrame: Up to two years
measure: Healthcare resources utilisation
timeFrame: Up to two years
Other outcomes:
Locations:
city: Multiple Locations
country: France
facility: Many Locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Fauchier L, Blin P, Sacher F, Dureau-Pournin C, Bernard MA, Lassalle R, Droz-Perroteau C, Dallongeville J, Moore N. Reduced dose of rivaroxaban and dabigatran vs. vitamin K antagonists in very elderly patients with atrial fibrillation in a nationwide cohort study. Europace. 2020 Feb 1;22(2):205-215. doi: 10.1093/europace/euz285.