NCT02742480

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 28, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 20, 2018

Status Verified

March 1, 2018

Enrollment Period

2.9 years

First QC Date

April 8, 2016

Last Update Submit

March 19, 2018

Conditions

Cardioembolic Stroke

Keywords

strokeoral anticoagulantscardioembolic

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

Interventions

DabigatranDRUG
Dabigatran
AcenocoumarolDRUG
Acenocoumarol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, 08221, Spain

RECRUITING

MeSH Terms

Conditions

Embolic StrokeStroke

Interventions

DabigatranAcenocoumarol

Condition Hierarchy (Ancestors)

Ischemic StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring4-HydroxycoumarinsCoumarinsBenzopyransPyrans

Central Study Contacts

Jerzy Krupinski

CONTACT

93 7365050jkrupinski@mutuaterrassa.es

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2016

First Posted

April 19, 2016

Study Start

June 28, 2016

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

March 20, 2018

Record last verified: 2018-03

Locations

ES(1)