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Cognitive Impairment Related to Atrial Fibrillation Prevention Trial (GIRAF)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Warfarin
Dabigatran
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Cognition, Cognitive impairment, Anticoagulation, Dabigatran, Warfarin, Efficacy

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Federal Univeristy of Minas Gerais
  • Heart Institute - University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Warfarin

Dabigatran

Arm Description

Treatment with Warfarin once daily, taken at fast, to maintain INR between 2 and 3.

Dabigatran 150 mg twice daily

Outcomes

Primary Outcome Measures

Cognitive impairment
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
Comparison of thrombin generation test between the two treatment groups.

Full Information

First Posted
November 9, 2013
Last Updated
September 28, 2021
Sponsor
University of Sao Paulo
Collaborators
Federal University of Minas Gerais, Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01994265
Brief Title
Cognitive Impairment Related to Atrial Fibrillation Prevention Trial
Acronym
GIRAF
Official Title
Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 7, 2014 (undefined)
Primary Completion Date
March 9, 2021 (Actual)
Study Completion Date
March 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Federal University of Minas Gerais, Boehringer Ingelheim

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Cognition, Cognitive impairment, Anticoagulation, Dabigatran, Warfarin, Efficacy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Warfarin
Arm Type
Active Comparator
Arm Description
Treatment with Warfarin once daily, taken at fast, to maintain INR between 2 and 3.
Arm Title
Dabigatran
Arm Type
Active Comparator
Arm Description
Dabigatran 150 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Marevan, Coumadin
Intervention Description
Warfarin once daily, at fast, targeting INR between 2 and 3
Intervention Type
Drug
Intervention Name(s)
Dabigatran
Other Intervention Name(s)
Dabigatran 150 mg twice daily
Primary Outcome Measure Information:
Title
Cognitive impairment
Description
Cognitive impairment at two years, independently of stroke or other cerebrovascular events.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Number of Participants with less important alteration in coagulation test as a Measure of Safety
Description
Comparison of thrombin generation test between the two treatment groups.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Caramelli, Professor
Organizational Affiliation
Heart Institute, University of Sao Paulo, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal Univeristy of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130100
Country
Brazil
Facility Name
Heart Institute - University of São Paulo
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
36284318
Citation
Caramelli B, Yu PC, Cardozo FAM, Magalhaes IR, Spera RR, Amado DK, Escalante-Rojas MC, Gualandro DM, Calderaro D, Tavares CAM, Borges-Junior FA, Pastana AF, Matheus MG, Brucki SMD, Rodrigues ACO, Nitrini R, Caramelli P. Effects of dabigatran versus warfarin on 2-year cognitive outcomes in old patients with atrial fibrillation: results from the GIRAF randomized clinical trial. BMC Med. 2022 Oct 26;20(1):374. doi: 10.1186/s12916-022-02563-2.
Results Reference
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Cognitive Impairment Related to Atrial Fibrillation Prevention Trial

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