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
|Condition or disease||Intervention/treatment|
|Cardioembolic Stroke||Drug: Dabigatran Drug: Acenocoumarol|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|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|
300 patients treated with dabigatran under the habitual clinical practice.
200 patients treated with acenocoumarol under the habitual clinical practice.
- 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).
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
|Contact: Jerzy Krupinski||93 firstname.lastname@example.org|
|Hospital Universitari Mutua Terrassa||Recruiting|
|Terrassa, Barcelona, Spain, 08221|
|Contact: Pilar Arcusa email@example.com|