Cognitive Impairment Related to Atrial Fibrillation Prevention Trial

• Status: Completed
• Trial end date: 2021-03-09
• Target enrollment: 0
• Participant gender: 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 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Collaborators: Boehringer Ingelheim; Federal University of Minas Gerais
• Treatments: 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%