Real-life anticoagulants comparative benefit-risk in nonvalvular atrial fibrillation (NVAF) in France (ENGEL 2)

Study identification

• EU PAS number:
  EUPAS13017
• Study ID:
  49819
• Official title and acronym:
  Real-life anticoagulants comparative benefit-risk in nonvalvular atrial fibrillation (NVAF) in France (ENGEL 2)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The research question is to compare the 1-year and long-term benefit-risk between each of direct oral anticoagulant (DOAC) (Pradaxa®, Xarelto®) vs vitamin K (VKA) for new users in nonvalvular atrial fibrillation (NVAF). The main objective is to compare the 1-year risk of major bleeding, stroke and systemic embolism (SSE) (prior named “arterial thrombotic events” as in the protocol and the study report “One-year of follow-up”), myocardial infarction (MI) and death for each DOAC (dabigatran, rivaroxaban) vs VKA in NVAF during drug exposure. The secondary objectives are to compare healthcare resources use and their related costs during drug exposure on the 1-year of follow-up, and the long-term risk (2 and 3-year) of the same outcomes for each DOAC vs VKA and for dabigatran vs rivaroxaban according to the initial DOAC doses. This is a cohort study in the French natiowide claims database including new users of DOAC or VKA in NVAF in 2013 with a follow-up until 31 December 2016, and 3 years history. The index date will be that of the first dispensing of DOAC or VKA in 2013. Data will be extracted from 2010 to 2016. 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 institutions and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual: 19/12/2014

Study start date

Actual: 05/04/2016

Data analysis start date

Actual: 25/04/2016

Date of interim report, if expected

Actual: 25/10/2018

Date of final study report

Planned: 31/10/2019

Actual: 20/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim France

Regulatory

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

Other study registration identification numbers and links

ClinicalTrial.gov: NCT02785354