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Trial record 71 of 333 for:    DABIGATRAN

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

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ClinicalTrials.gov Identifier: NCT02742480
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital Mutua de Terrassa

Brief 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.

Condition or disease Intervention/treatment
Cardioembolic Stroke 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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Dabigatran Study in the Early Phase of Stroke. New Neuroimaging Markers and Biomarkers Study (SEDMAN STUDY)
Actual Study Start Date : June 28, 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Stroke (including TIA) or systemic embolism (Efficacy) [ Time Frame: 1 year ]
    Efficacy will be defined as stroke (including TIA) or systemic embolism

  2. Any type of hemorrhage (clinically minor and major bleeding) [ Time Frame: 1 year ]
    Safety variable will include any type of hemorrhage (clinically minor and major bleeding).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742480


Contacts
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Contact: Jerzy Krupinski 93 7365050 jkrupinski@mutuaterrassa.es

Locations
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Spain
Hospital Universitari Mutua Terrassa Recruiting
Terrassa, Barcelona, Spain, 08221
Contact: Pilar Arcusa       parcusa@mutuaterrassa.es   
Sponsors and Collaborators
Hospital Mutua de Terrassa

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Responsible Party: Hospital Mutua de Terrassa
ClinicalTrials.gov Identifier: NCT02742480     History of Changes
Other Study ID Numbers: JKB-DAB-2016-01
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Keywords provided by Hospital Mutua de Terrassa:
stroke
oral anticoagulants
cardioembolic
Additional relevant MeSH terms:
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Dabigatran
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Acenocoumarol
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants