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Cognitive Impairment Related to Atrial Fibrillation Prevention Trial (GIRAF)

This study is currently recruiting participants.
Verified October 2017 by Bruno Caramelli, University of Sao Paulo
Sponsor:
ClinicalTrials.gov Identifier:
NCT01994265
First Posted: November 25, 2013
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Federal University of Minas Gerais
Boehringer Ingelheim
Information provided by (Responsible Party):
Bruno Caramelli, University of Sao Paulo
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Single (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 Bruno Caramelli, University of Sao Paulo:

Primary Outcome Measures:
  • Cognitive impairment [ Time Frame: Two years ]
    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 ]
    Comparison of thrombin generation test between the two treatment groups.


Estimated Enrollment: 200
Study Start Date: October 2014
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: June 2018 (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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994265


Contacts
Contact: Bruno Caramelli, Professor +551126615376 bcaramel@usp.br
Contact: Adriana F Pastana +551126615376 adriana.pastana@usp.br

Locations
Brazil
Federal Univeristy of Minas Gerais Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130100
Contact: Paulo Caramelli, Professor       caramelli@ufmg.br   
Heart Institute - University of São Paulo Recruiting
São Paulo, Brazil, 05403-000
Contact: Bruno Caramelli, Ph.D.    +551126615376    bcaramel@usp.br   
Contact: Pai C Yu, Ph.D.    +551126615376    paichingyu@gmail.com   
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
Investigators
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
ClinicalTrials.gov Identifier: NCT01994265     History of Changes
Other Study ID Numbers: USP/UFMG 2013
First Submitted: November 9, 2013
First Posted: November 25, 2013
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Bruno Caramelli, University of Sao Paulo:
Atrial fibrillation
Cognition
Cognitive impairment
Anticoagulation
Dabigatran
Warfarin
Efficacy

Additional relevant MeSH terms:
Warfarin
Atrial Fibrillation
Cognitive Dysfunction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dabigatran
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action