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Cognitive Impairment Related to Atrial Fibrillation Prevention Trial (GIRAF)

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ClinicalTrials.gov Identifier: NCT01994265
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : September 29, 2021
Sponsor:
Collaborators:
Federal University of Minas Gerais
Boehringer Ingelheim
Information provided by (Responsible Party):
Bruno Caramelli, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE November 9, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date September 29, 2021
Study Start Date  ICMJE November 7, 2014
Actual Primary Completion Date March 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
Cognitive impairment [ Time Frame: Two years ]
Cognitive impairment at two years, independently of stroke or other cerebrovascular events.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Impairment Related to Atrial Fibrillation Prevention Trial
Official Title  ICMJE Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin
Brief Summary 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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Drug: Warfarin
    Warfarin once daily, at fast, targeting INR between 2 and 3
    Other Name: Marevan, Coumadin
  • Drug: Dabigatran
    Other Name: Dabigatran 150 mg twice daily
Study Arms  ICMJE
  • Active Comparator: Warfarin
    Treatment with Warfarin once daily, taken at fast, to maintain INR between 2 and 3.
    Intervention: Drug: Warfarin
  • Active Comparator: Dabigatran
    Dabigatran 150 mg twice daily
    Intervention: Drug: Dabigatran
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2013)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 9, 2021
Actual Primary Completion Date March 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994265
Other Study ID Numbers  ICMJE USP/UFMG 2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bruno Caramelli, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE
  • Federal University of Minas Gerais
  • Boehringer Ingelheim
Investigators  ICMJE
Principal Investigator: Bruno Caramelli, Professor Heart Institute, University of Sao Paulo, Brazil
PRS Account University of Sao Paulo
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP