Cognitive Impairment Related to Atrial Fibrillation Prevention Trial (GIRAF)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by University of Sao Paulo
Sponsor:
Collaborators:
Federal University of Minas Gerais
Boehringer Ingelheim
Information provided by (Responsible Party):
Bruno Caramelli, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01994265
First received: November 9, 2013
Last updated: April 19, 2014
Last verified: April 2014
  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
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: May 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).

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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 Not yet recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130100
Contact: Paulo Caramelli, Professor       caramelli@ufmg.br   
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

No publications provided

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
Study First Received: November 9, 2013
Last Updated: April 19, 2014
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Warfarin
Atrial Fibrillation
Cognition Disorders
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dabigatran
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014