Study identification

PURI

https://redirect.ema.europa.eu/resource/33157

EU PAS number

EUPAS13470

Study ID

33157

Official title and acronym

Beyond Pooled – Part of the BEYOND study program (Benefit of NOACs study of non-valvular AF patients in nordic countries) (BEYOND Pooled (Denmark, Norway, Sweden))

DARWIN EU® study

No

Study countries

Denmark
Norway
Sweden

Study description

The overall aim of this study is to evaluate effectiveness and safety of each NOAC compared with warfarin in treatment-naïve initiators of anticoagulants with NVAF in routine clinical practice in Denmark, Norway and Sweden. The study will use pooled data from nationwide registries in Denmark, Norway and Sweden.

Study status

Finalised
Research institutions and networks

Institutions

Department of Clinical Epidemiology Olof Palmes Allé 43-45, Department of Global Public Health and Primary Care Kalfarveien 31, NO-5018 Bergen, Norway

Contact details

Vera Ehrenstein

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer, Inc.
Study protocol
Initial protocol

BEYOND Pooled Protocol FINAL approved 28 Sep 2017

English (1.24 MB - PDF)View document
Updated protocol

B0661103 BEYOND Pooled Protocol 2018-07-05 amendment 1_1 signed off

English (1.05 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable