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Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02742480
Study type Observational
Source Hospital Mutua de Terrassa
Contact Jerzy Krupinski
Phone 93 7365050
Email jkrupinski@mutuaterrassa.es
Status Recruiting
Phase
Start date June 28, 2016
Completion date December 2019

See also
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Completed NCT02181361 - Hirudin Plus Aspirin in the Secondary Prevention of Cardioembolic Stroke Due to Nonvalvular Atrial Fibrillation
Not yet recruiting NCT06232278 - Long-term Results of Percutaneous Left Atrial Closure at Brest University Hospital (CLAPOT)
Completed NCT02014896 - Ischemia Care Biomarkers of Acute Stroke Etiology (BASE)
Active, not recruiting NCT05498909 - A Real-world Registry Study of Multidisciplinary Collaborative Diagnosis and Treatment Model for Cardioembolic Stroke
Recruiting NCT03897478 - Biomarkers of Acute Stroke in Clinic