Cognitive Impairment Related to Atrial Fibrillation Prevention Trial (GIRAF)
Cognitive and functional decline observed in atrial fibrillation (AF) patients are related to thrombotic and/or cardioembolic events. Use of warfarin for the prevention of stroke in AF patients, despite effective, remains beyond desired levels because of interactions with food and fluctuations in blood levels. Because of a more stable anticoagulation state, Dabigatran may offer better protection against thrombotic phenomenon and, consequently, mitigate the process of cognitive and functional compromise.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin|
- Cognitive impairment [ Time Frame: Two years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]Comparison of thrombin generation test between the two treatment groups.
|Study Start Date:||October 2014|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
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
This will be a prospective parallel study including two hundred atrial fibrillation patients > 65 years old and scoring CHADS2VASc > 1. Patients will be randomized to receive Warfarin (INR between 2 and 3) or Dabigatran (150 mg twice daily) for two years. After one year and at the end of the study, individuals will be evaluated regarding cognitive endpoints following the National Institute of Neurological Disorders and Stroke-Canadian Stroke Network Vascular Cognitive Impairment Harmonization Standards (Hachinski et al. Stroke 2006;37:2220-2241). The investigators will use the 60 minutes evaluation protocol complemented by the Montreal Cognitive Assessment (MoCA).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01994265
|Contact: Bruno Caramelli, Professorfirstname.lastname@example.org|
|Contact: Adriana F Pastanaemail@example.com|
|Federal Univeristy of Minas Gerais||Recruiting|
|Belo Horizonte, Minas Gerais, Brazil, 30130100|
|Contact: Paulo Caramelli, Professor firstname.lastname@example.org|
|Heart Institute - University of São Paulo||Recruiting|
|São Paulo, Brazil, 05403-000|
|Contact: Bruno Caramelli, Ph.D. +551126615376 email@example.com|
|Contact: Pai C Yu, Ph.D. +551126615376 firstname.lastname@example.org|
|Principal Investigator: Bruno Caramelli, Ph.D.|
|Sub-Investigator: Pai C Yu, Ph.D.|
|Principal Investigator:||Bruno Caramelli, Professor||Heart Institute, University of Sao Paulo, Brazil|