Overview

Dabigatran Study in the Early Phase of Stroke. New Neuroimaging Markers and Biomarkers Study (SEDMAN STUDY)

Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
All
Summary
SEDMAN study is a prospective multicenter investigator initiated study (IIS). The main idea is to look 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 Acenocoumarol to determine if genetic risk factors are associated with the occurrence of any bleeding or vascular event in a year follow-up.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital Mutua de Terrassa
Treatments:
Acenocoumarol
Dabigatran
Criteria
Inclusion Criteria:

- Patients of both sexes who are ≥ 18 years of age

- Patients with stroke or TIA in last 14 days and a diagnosis of non-valvular atrial
fibrillation who initiate treatment with dabigatran or classical ACOs (acenocoumarol)
to prevent stroke or non-CNS systemic embolism.

- Patients with mild/moderate strokes (i.e. strokes less than 2/3 of vascular territory
with initial ASPECTS on first CT/MRI > 6 and NIHSS <25).

- Patients who have an overall condition which allow the 12 months' follow-up.

Exclusion Criteria:

- Patients with an indication of oral anticoagulants for primary prevention or with an
indication other than cardioembolic etiology.

- Patients with contraindications to use anticoagulants.

- Patients who do not wish to participate in the study and have not signed informed
consent.

- Patients with non-controlled hypertension or hypertensive crisis will be also
excluded.

- Patients with a life expectancy of less than one year.

- Patients with psychological or social factor which not allow a correct follow-up.

- Patients with severe/disabling strokes (i.e. more than 2/3 of vascular territory,
NIHSS≥25).