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Completed

NCT Number: NCT01994265

Cognitive Impairment Related to Atrial Fibrillation Prevention Trial

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Heart Diseases Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Federal Univeristy of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Warfarin

Drug

Warfarin once daily, at fast, targeting INR between 2 and 3

Other names: Marevan, Coumadin

dabigatran

Drug

Other names: Dabigatran 150 mg twice daily

Primary outcomes

  1. Cognitive impairment

    Time frame: Two years

    Cognitive impairment at two years, independently of stroke or other cerebrovascular events.

Secondary outcomes

  1. Number of Participants with less important alteration in coagulation test as a Measure of Safety

    Time frame: Two years

    Comparison of thrombin generation test between the two treatment groups.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Boehringer Ingelheim
  • Federal University of Minas Gerais

Registry information

Official study title

Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin

Acronym: GIRAF

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2013
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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