Study identification

EU PAS number

EUPAS9374

Study ID

17585

Official title and acronym

Stroke Prevention and anticoagulants (SPA)

DARWIN EU® study

No

Study countries

France

Study description

The primary objective of this study is to assess the relative risk of stroke (ischaemic or haemorrhagic stroke) in patients with atrial fibrillation using dabigatran and in those using other new oral anticoagulant therapies (rivaroxaban, apixaban) as compared to the use of any vitamin K antagonist (VKA: fluindione, acenocoumarol or warfarin), For clarity, an odds ratio will be estimated for dabigatran vs. VKA (any), for rivaroxaban vs. VKA (any) and for apixaban vs. VKA. The study is powered for the assessment of dabigatran use vs. VKA (any) use.Secondary objectives:• To describe the patterns of use of dabigatran and other anticoagulant therapies in non-valvular atrial fibrillation• To assess the risk of haemorrhage in patients participating in the study treated with anticoagulants (dabigatran, rivaroxaban, apixaban, VKA) • To assess what risk factors influence the risk of stroke in patients with and without the different anticoagulant therapiesThe study design is a systematic case-referentThe sample size of 2.650 cases and 5.300 controls is estimated as necessary to detect an odds ratio of 0.80 with 95% confidence and 80% power assuming that 20% of referents (patients with atrial fibrillation and no stroke) will be exposed to dabigatran on average during the study period

Study status

Ongoing
Research institutions and networks

Institutions

Networks

PGRx®
France
United Kingdom
First published:
17/01/2012
Network
Outdated
ENCePP partner

Contact details

Lamiae Grimaldi

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable