Dabigatran study in the early phase of stroke. New neuroimaging markers and biomarkers study (SEDMAN STUDY)

Study identification

• EU PAS number:
  EUPAS12878
• Study ID:
  26079
• Official title and acronym:
  Dabigatran study in the early phase of stroke. New neuroimaging markers and biomarkers study (SEDMAN STUDY)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  SEDMAN study is a prospective multicenter study. The main idea is to look for the first time by Genome Wide Association (arrays that determine more than 1 million polymorphisms) genetic risk factors associated with response to dabigatran. To conduct the study, the goal is to recruit 300 patients with ischemic stroke with cardioembolic etiology treated with dabigatran and 200 treated with Acenocumarol to determine if genetic risk factors are associated with the occurrence of any bleeding or vascular event in a year follow-up.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Hospital Universitari Mútua Terrassa

Study timelines

Date when funding contract was signed

Planned:15/05/2015

Actual:15/05/2018

Study start date

Planned:24/03/2016

Actual:28/06/2016

Data analysis start date

Planned:21/03/2018

Actual:23/04/2018

Date of final study report

Planned:01/08/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boeringher ingelheim

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable