Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
- Conditions
- Atrial Fibrillation
- Interventions
- Registration Number
- NCT02864758
- Lead Sponsor
- Bayer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99999
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 3 dabigatran (Pradaxa) Adult patients with nonvalvular atrial fibrillation (NVAF) treated with dabigatran Group 2 Vitamin K antagonists Adult patients with nonvalvular atrial fibrillation (NVAF) treated with vitamin k anatognists Group 1 Rivaroxaban (Xarelto, BAY59-7939) Adult patients with nonvalvular atrial fibrillation (NVAF) treated with rivaroxaban
- Primary Outcome Measures
Name Time Method Major Bleeding One year and Two Year 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.Death One year and Two Year 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.
Stroke and systemic embolism (Effectiveness outcome) One year and Two Year 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.
- Secondary Outcome Measures
Name Time Method A composite of stroke and SE, major bleeding and death, clinically relevant bleeding and acute coronary syndrome One year and Two Year 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
Pattern of use (Exposure, Adherence, Discontinuation, Switch) Up to two years To describe the drug exposure to rivaroxaban, dabigatran, and VKA for SPAF in new users and pattern of use
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 Post-anticoagulant exposure for rivaroxaban, dabigatran, and VKA (i.e. after anticoagulant discontinuation)
Healthcare resources utilisation Up to two years 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)
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 During drug exposure for rivaroxaban, dabigatran, and VKA
Trial Locations
- Locations (1)
Many Locations
🇫🇷Multiple Locations, France