Study identification

PURI

https://redirect.ema.europa.eu/resource/49819

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 institution and networks

Institutions

Contact details

Nicholas Moore

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Actual:

Start date of data analysis

Actual:

Date of interim report, if expected

Actual:

Date of final study report

Planned:
Actual:
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