Overview
Cognitive Impairment Related to Atrial Fibrillation Prevention Trial
Status:
Completed
Completed
Trial end date:
2021-03-09
2021-03-09
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of Sao PauloCollaborators:
Boehringer Ingelheim
Federal University of Minas GeraisTreatments:
Dabigatran
Warfarin
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
- Uncontrolled hypertension
- Active cancer
- Contraindication for Warfarin use
- Reversible causes of atrial fibrillation
- Creatinine clearance < 30 ml/min
- Active endocarditis
- Active hepatitis
- Severe anemia
- Left ventricle ejection fraction < 35%