Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin
Overview
- Phase
- Phase 4
- Intervention
- Warfarin
- Conditions
- Atrial Fibrillation
- Sponsor
- University of Sao Paulo
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Cognitive impairment
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Bruno Caramelli
Associate Professor of Cardiology
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- •Atrial fibrillation
- •CHA2DS2-VASc Score for Atrial Fibrillation Stroke Risk (CHADS2VASc) greater than 1
Exclusion Criteria
- •Heart valve disease
- •Previous Stroke or Transient ischemic attack
- •Cognitive impairment or any severe neurological disorder
- •Major surgery in the last 30 days
- •Planned elective surgery in the next three months
- •Intracranial, ocular, spinal, retroperitoneal, or articular bleeding without trauma.
- •Gastrointestinal bleeding in the last 12 months
- •Symptomatic gastric ulcer
- •Hemorrhagic disease
- •Use of thrombolytics
Arms & Interventions
Warfarin
Treatment with Warfarin once daily, taken at fast, to maintain INR between 2 and 3.
Intervention: Warfarin
Dabigatran
Dabigatran 150 mg twice daily
Intervention: Dabigatran
Outcomes
Primary Outcomes
Cognitive impairment
Time Frame: Two years
Cognitive impairment at two years, independently of stroke or other cerebrovascular events.
Secondary Outcomes
- Number of Participants with less important alteration in coagulation test as a Measure of Safety(Two years)