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

NCT02864758 | Completed

• 1 other identifier: 18656
• Study Type: observational
• Target: 99,999
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Pattern of use (Exposure, Adherence, Discontinuation, Switch)

  Up to two years

• A composite of stroke and SE, major bleeding and death, clinically relevant bleeding and acute coronary syndrome

  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 outcomes

  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 outcomes

  Up to two years

• Healthcare resources utilisation

  Up to two years

Study Arms (3)

Group 1

Adult patients with nonvalvular atrial fibrillation (NVAF) treated with rivaroxaban

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Group 2

Adult patients with nonvalvular atrial fibrillation (NVAF) treated with vitamin k anatognists

Drug: Vitamin K antagonists

Group 3

Adult patients with nonvalvular atrial fibrillation (NVAF) treated with dabigatran

Drug: dabigatran (Pradaxa)

Interventions

Rivaroxaban (Xarelto, BAY59-7939) DRUG

Tablets, 20mg once daily

Group 1

Vitamin K antagonists DRUG

Tablets, dose is based on International Normalized Ratio

Group 2

dabigatran (Pradaxa) DRUG

Tablets, 150 mg twice daily

Group 3

Eligibility Criteria

• Age: 2 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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),

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Many Locations

Multiple Locations, France

Location

Related Publications (2)

• 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.

  PMID: 31390972 BACKGROUND

• 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.

  PMID: 31638652 DERIVED

Related Links

• Click here to find results for studies related to Bayer products.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban; acarboxyprothrombin; Dabigatran

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: September 8, 2016
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

FR (1)