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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dabigatran | 300 patients treated with dabigatran under the habitual clinical practice. |
| |
| Acenocoumarol | 200 patients treated with acenocoumarol under the habitual clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran | Drug |
| ||
| Acenocoumarol |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke (including TIA) or systemic embolism (Efficacy) | Efficacy will be defined as stroke (including TIA) or systemic embolism | 1 year |
| Any type of hemorrhage (clinically minor and major bleeding) | Safety variable will include any type of hemorrhage (clinically minor and major bleeding). | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of both sexes who are at least 18 years of age with a diagnosis of non-valvular atrial fibrillation and stroke or TIA and after taking the decision to perform pharmacological prophylaxis with dabigatran or acenocoumarol under the approved indication and the recommendations.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jerzy Krupinski | Contact | 93 7365050 | jkrupinski@mutuaterrassa.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Mutua Terrassa | Recruiting | Terrassa | Barcelona | 08221 | Spain |
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| ID | Term |
|---|---|
| D000083262 | Embolic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| D000074 | Acenocoumarol |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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|
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |