Cognitive Impairment Related to Atrial Fibrillation Prevention Trial (GIRAF)

September 28, 2021 updated by: Bruno Caramelli, University of Sao Paulo

Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-000
        • Heart Institute - University of São Paulo
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130100
        • Federal Univeristy of Minas Gerais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Marevan, Coumadin
ACTIVE_COMPARATOR: Dabigatran
Dabigatran 150 mg twice daily
Drug: Dabigatran
Other Names:
  • Dabigatran 150 mg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive impairment
Time Frame: Two years
Cognitive impairment at two years, independently of stroke or other cerebrovascular events.
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Boehringer Ingelheim
Federal University of Minas Gerais

Investigators

  • Principal Investigator: Bruno Caramelli, Professor, Heart Institute, University of Sao Paulo, Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 7, 2014

Primary Completion (ACTUAL)

March 9, 2021

Study Completion (ACTUAL)

March 9, 2021

Study Registration Dates

First Submitted

November 9, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (ESTIMATE)

November 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USP/UFMG 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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