Study identification

EU PAS number

EUPAS17165

Study ID

36112

Official title and acronym

Pradaxa Initiation Post-Stroke Study: SITS-Pradaxa 1. A retrospective analysis from the SITS-AF Registry on treatment initiation of dabigatran etexilate in non-valvular atrial fibrillation patients hospitalized with acute ischemic stroke

DARWIN EU® study

No

Study countries

Austria
Belgium
Croatia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Italy
Lithuania
Netherlands
Norway
Poland
Portugal
Slovakia
Slovenia
Spain
Sweden
Ukraine
United Kingdom

Study description

This is an observational study in patients with non-valvular atrial fibrillation (NVAF) presenting to the hospital with a first acute ischemic stroke based on existing data recorded in the SITS International Registry (located in Sweden) by physicians in several European countries. The aim of this study is to explore the current real world use of dabigatran for stroke prevention in NVAF patients in the post-stroke setting. Data from eligible European patients registered in the SITS Registry will be considered, countries of origin are not known a priori.

Study status

Finalised
Research institutions and networks

Institutions

Networks

SITS International Network

Contact details

Christine Teutsch

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

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

More details on funding

Boehringer Ingelheim
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable