Stroke Prevention and anticoagulants (SPA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17585
• 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

Real World Studies, LA-SER Research

France

United Kingdom

Networks

PGRx®

France

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 20/12/2012

Study start date

Actual: 05/12/2013

Data analysis start date

Planned: 02/11/2016

Date of final study report

Planned: 24/01/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Study protocol

Initial protocol

SPA_Executive summary of protocol

Updated protocol

SPA_Executive summary of protocol_20160129

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable