Cognitive Impairment Related to Atrial Fibrillation Prevention Trial (GIRAF)
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|ClinicalTrials.gov Identifier: NCT01994265|
Recruitment Status : Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: Warfarin Drug: Dabigatran||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin|
|Study Start Date :||November 7, 2014|
|Estimated Primary Completion Date :||March 23, 2020|
|Estimated Study Completion Date :||March 23, 2021|
Active Comparator: Warfarin
Treatment with Warfarin once daily, taken at fast, to maintain INR between 2 and 3.
Warfarin once daily, at fast, targeting INR between 2 and 3
Other Name: Marevan, Coumadin
Active Comparator: Dabigatran
Dabigatran 150 mg twice daily
Other Name: Dabigatran 150 mg twice daily
- Cognitive impairment [ Time Frame: Two years ]Cognitive impairment at two years, independently of stroke or other cerebrovascular events.
- Number of Participants with less important alteration in coagulation test as a Measure of Safety [ Time Frame: Two years ]Comparison of thrombin generation test between the two treatment groups.
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): NCT01994265
|Federal Univeristy of Minas Gerais|
|Belo Horizonte, Minas Gerais, Brazil, 30130100|
|Heart Institute - University of São Paulo|
|São Paulo, Brazil, 05403-000|
|Principal Investigator:||Bruno Caramelli, Professor||Heart Institute, University of Sao Paulo, Brazil|