Trials / Unknown
UnknownNCT02742480
Dabigatran Study in the Early Phase of Stroke. New Neuroimaging Markers and Biomarkers Study (SEDMAN STUDY)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Hospital Mutua de Terrassa · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dabigatran | |
| DRUG | Acenocoumarol |
Timeline
- Start date
- 2016-06-28
- Primary completion
- 2019-06-01
- Completion
- 2019-12-01
- First posted
- 2016-04-19
- Last updated
- 2018-03-20
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT02742480. Inclusion in this directory is not an endorsement.