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

Sponsor

Hospital Mutua de Terrassa (Other)

Overall Status

Unknown status

CT.gov ID

NCT02742480

Collaborator

(none)

500

Enrollment

Location

41.1

Anticipated Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardioembolic Stroke	Drug: Dabigatran Drug: Acenocoumarol

Detailed Description

Data will be analyzed through GWAS analysis. The results will be analyzed by experienced genotypic bioinformatics: Plink, Haploview, STATA, IMPUTE2, SNPtest, GTOOL, Galaxy management. In addition, the investigators have support of Spanish Consortium for Genetics of Stroke (Genestroke). The PLINK software is the main program for the analysis of GWAS. Using this software we can clean the raw results of genotyping platforms and determine the presence of risk alleles associated with resistance to the study drugs. Haploview software will be used for data management and graphics for significance analysis. STATA statistical software is a data management and very useful for the creation of Q_Q plots graphs that assist in the interpretation of genotypic results. GTOOL, SNPtest and IMPUTE2 are software for data imputation and analysis of imputed data through the information available in the 1000 Genomes Project.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 28, 2016

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Dabigatran 300 patients treated with dabigatran under the habitual clinical practice.	Drug: Dabigatran
Acenocoumarol 200 patients treated with acenocoumarol under the habitual clinical practice.	Drug: Acenocoumarol

Arm

Intervention/Treatment

Dabigatran

300 patients treated with dabigatran under the habitual clinical practice.

Drug: Dabigatran

Acenocoumarol

200 patients treated with acenocoumarol under the habitual clinical practice.

Drug: Acenocoumarol

Outcome Measures

Primary Outcome Measures

Stroke (including TIA) or systemic embolism (Efficacy) [1 year]
Efficacy will be defined as stroke (including TIA) or systemic embolism
Any type of hemorrhage (clinically minor and major bleeding) [1 year]
Safety variable will include any type of hemorrhage (clinically minor and major bleeding).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).