Dabigatran Study in the Early Phase of Stroke. New Neuroimaging Markers and Biomarkers Study (SEDMAN STUDY)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Any type of hemorrhage (clinically minor and major bleeding)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Dabigatran
300 patients treated with dabigatran under the habitual clinical practice.
干预措施: Dabigatran (Drug)
Acenocoumarol
200 patients treated with acenocoumarol under the habitual clinical practice.
干预措施: Acenocoumarol (Drug)
结局指标
主要结局
Any type of hemorrhage (clinically minor and major bleeding)
时间窗: 1 year
Safety variable will include any type of hemorrhage (clinically minor and major bleeding).
Stroke (including TIA) or systemic embolism (Efficacy)
时间窗: 1 year
Efficacy will be defined as stroke (including TIA) or systemic embolism
次要结局
未报告次要终点