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 (BROTHER).

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49822
• EU PAS number:
  EUPAS14567
• Study ID:
  49822
• Official title and acronym:
  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 (BROTHER).
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The research question is to assess the one-year and two-year benefit-risk of rivaroxaban for stroke prevention in atrial fibrillation (SPAF) compared to vitamin K antagonists (VKA) and dabigatran among new anticoagulant users. The main objective is to compare the one-year and two-year risk of the following individual outcomes: stroke and systemic embolism (SSE), major bleeding and death, between new users of anticoagulant for SPAF during drug exposure: rivaroxaban versus VKA, and rivaroxaban versus dabigatran (standard and reduced doses). Secondary outcomes were clinically relevant bleeding (CRB), acute coronary syndrome (ACS) and a composite criterion of SSE, major bleeding or death. This is a cohort study in the French national healthcare claims and hospitalisation database (SNDS, Système National des Données de Santé) including new users of rivaroxaban, dabigatran, or VKA for SPAF with a follow-up for at least one year and up to two years per subject, and three-year history. The index date will be that of the first dispensation of rivaroxaban, dabigatran, or VKA in 2013 or 2014. Data will be extracted from 2010 to 2015. Outcomes analysis will be performed during drug exposure for matched patients on high-dimensional propensity score (hdPS), and all patients with hdPS adjustment.
• Study status:
  Finalised

Research institution and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual: 01/02/2016

Study start date

Actual: 24/08/2016

Data analysis start date

Actual: 16/11/2016

Date of final study report

Actual: 20/11/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer Pharma AG

Study protocol

Initial protocol

BROTHER_ENCePP_Protocol_V1.0_20181203

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable