Study identification

EU PAS number

EUPAS16014

Study ID

46296

Official title and acronym

Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU

DARWIN EU® study

No

Study countries

Denmark
France
Germany
Netherlands
Spain

Study description

This study is using longitudinal data collected in 8 electronic health care databases from six EU countries to characterize the risk of major bleeding in Direct Oral Anticoagulant (DOAC) users in a real-world setting to help establish the effectiveness of existing and future risk minimization measures. The research undertaken will focus on targeted clinical and demographic subgroups for which variations in plasma concentrations might affect the safety of the products.

Study status

Finalised
Research institutions and networks

Institutions

Networks

Contact details

Helga Gardarsdottir

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of interim report, if expected

Actual:

Date of final study report

Actual:
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable