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

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.

Study Overview

• Status: Unknown
• Conditions: Cardioembolic Stroke
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Jerzy Krupinski; Phone Number: 93 7365050; Email: jkrupinski@mutuaterrassa.es

Study Locations

• Spain
  • Barcelona
    • Terrassa, Barcelona, Spain, 08221
      • Recruiting
      • Hospital Universitari Mútua Terrassa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospital Mutua de Terrassa

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2016
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: April 8, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: stroke; oral anticoagulants; cardioembolic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ischemic Stroke; Stroke; Embolic Stroke; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Dabigatran; Acenocoumarol
• Other Study ID Numbers: JKB-DAB-2016-01