Cognitive Impairment Related to Atrial Fibrillation Prevention Trial (GIRAF)

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: Dabigatran; Drug: Warfarin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01994265

USP/UFMG 2013

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Warfarin

Active Comparator group

Description:

Treatment with Warfarin once daily, taken at fast, to maintain INR between 2 and 3.

Treatment:

Drug: Warfarin

Dabigatran

Active Comparator group

Description:

Dabigatran 150 mg twice daily

Treatment:

Drug: Dabigatran