Cognitive Impairment Related to Atrial Fibrillation Prevention Trial (GIRAF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by University of Sao Paulo
Federal University of Minas Gerais
Boehringer Ingelheim
Information provided by (Responsible Party):
Bruno Caramelli, University of Sao Paulo Identifier:
First received: November 9, 2013
Last updated: November 30, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Atrial Fibrillation
Drug: Warfarin
Drug: Dabigatran
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Cognitive impairment [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Cognitive impairment at two years, independently of stroke or other cerebrovascular events.

Secondary Outcome Measures:
  • Number of Participants with less important alteration in coagulation test as a Measure of Safety [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    Comparison of thrombin generation test between the two treatment groups.

Estimated Enrollment: 200
Study Start Date: October 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Warfarin
Treatment with Warfarin once daily, taken at fast, to maintain INR between 2 and 3.
Drug: Warfarin
Warfarin once daily, at fast, targeting INR between 2 and 3
Other Name: Marevan, Coumadin
Active Comparator: Dabigatran
Dabigatran 150 mg twice daily
Drug: Dabigatran
Other Name: Dabigatran 150 mg twice daily

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).

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01994265

Contact: Bruno Caramelli, Professor +551126615376
Contact: Adriana F Pastana +551126615376

Federal Univeristy of Minas Gerais Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130100
Contact: Paulo Caramelli, Professor   
Heart Institute - University of São Paulo Recruiting
São Paulo, Brazil, 05403-000
Contact: Bruno Caramelli, Ph.D.    +551126615376   
Contact: Pai C Yu, Ph.D.    +551126615376   
Principal Investigator: Bruno Caramelli, Ph.D.         
Sub-Investigator: Pai C Yu, Ph.D.         
Sponsors and Collaborators
University of Sao Paulo
Federal University of Minas Gerais
Boehringer Ingelheim
Principal Investigator: Bruno Caramelli, Professor Heart Institute, University of Sao Paulo, Brazil
  More Information

Responsible Party: Bruno Caramelli, Associate Professor of Cardiology, University of Sao Paulo Identifier: NCT01994265     History of Changes
Other Study ID Numbers: USP/UFMG 2013 
Study First Received: November 9, 2013
Last Updated: November 30, 2015
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Atrial fibrillation
Cognitive impairment

Additional relevant MeSH terms:
Atrial Fibrillation
Cognition Disorders
Arrhythmias, Cardiac
Cardiovascular Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Heart Diseases
Mental Disorders
Pathologic Processes
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses processed this record on May 04, 2016