Cardioembolic StrokeSEDMANNCT02742480
Dabigatran Study in the Early Phase of Stroke. New Neuroimaging Markers and Biomarkers Study (SEDMAN STUDY)
An observational study of Cardioembolic Stroke, run by Hospital Mutua de Terrassa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardioembolic Stroke
- What is being tested?
- Dabigatran and Acenocoumarol
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jun 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, 08221
Pilar Arcusa, parcusa@mutuaterrassa.es
About this study
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.
Read the 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
- Cardioembolic Stroke
- Being tested
- Dabigatran, Acenocoumarol
- Keywords
- stroke, oral anticoagulants, cardioembolic
- Medical subject headings
- Embolic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabigatranDrug
AcenocoumarolDrug
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran | 300 patients treated with dabigatran under the habitual clinical practice. Receives: Drug: Dabigatran | |
| Acenocoumarol | 200 patients treated with acenocoumarol under the habitual clinical practice. Receives: Drug: Acenocoumarol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke (including TIA) or systemic embolism (Efficacy)
Efficacy will be defined as stroke (including TIA) or systemic embolism
Measured: 1 year
Any type of hemorrhage (clinically minor and major bleeding)
Safety variable will include any type of hemorrhage (clinically minor and major bleeding).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start28 Jun 2016
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardioembolic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742480
- Sponsor's protocol ID
- JKB-DAB-2016-01
- Acronym
- SEDMAN
- Status last verified
- Mar 2018
- First submitted
- 8 Apr 2016
- Last updated
- 20 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dabigatran Study in the Early Phase of Stroke. New Neuroimaging Markers and Biomarkers Study (SEDMAN STUDY)
- ClinicalTrials.gov ID
- NCT02742480
- Acronym / sponsor ID
- SEDMAN / JKB-DAB-2016-01
- Conditions
- Cardioembolic Stroke
- Keywords
- stroke, oral anticoagulants, cardioembolic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Study start
- 28 Jun 2016 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran | – | Drug: Dabigatran300 patients treated with dabigatran under the habitual clinical practice. |
| Acenocoumarol | – | Drug: Acenocoumarol200 patients treated with acenocoumarol under the habitual clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dabigatran | Drug | Dabigatran |
| Acenocoumarol | Drug | Acenocoumarol |
Primary outcome
Stroke (including TIA) or systemic embolism (Efficacy)
Time frame: 1 year
Efficacy will be defined as stroke (including TIA) or systemic embolism
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardioembolic Stroke, run by Hospital Mutua de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jerzy Krupinski (93 7365050, jkrupinski@mutuaterrassa.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke (including TIA) or systemic embolism (Efficacy) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.