NCT01994265

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_4 atrial-fibrillation

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
12 months until next milestone

Study Start

First participant enrolled

November 7, 2014

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

6.3 years

First QC Date

November 9, 2013

Last Update Submit

September 28, 2021

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationCognitionCognitive impairmentAnticoagulationDabigatranWarfarinEfficacy

Outcome Measures

Primary Outcomes (1)

  • Cognitive impairment

    Cognitive impairment at two years, independently of stroke or other cerebrovascular events.

    Two years

Secondary Outcomes (1)

  • Number of Participants with less important alteration in coagulation test as a Measure of Safety

    Two years

Study Arms (2)

Warfarin

ACTIVE COMPARATOR

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

Drug: Warfarin

Dabigatran

ACTIVE COMPARATOR

Dabigatran 150 mg twice daily

Drug: Dabigatran

Interventions

WarfarinDRUG

Warfarin once daily, at fast, targeting INR between 2 and 3

Also known as: Marevan, Coumadin
Warfarin
DabigatranDRUG
Also known as: Dabigatran 150 mg twice daily
Dabigatran

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Atrial fibrillation
  • CHA2DS2-VASc Score for Atrial Fibrillation Stroke Risk (CHADS2VASc) greater than 1

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Federal Univeristy of Minas Gerais

Belo Horizonte, Minas Gerais, 30130100, Brazil

Location

Heart Institute - University of São Paulo

São Paulo, 05403-000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 36284318DERIVED

MeSH Terms

Conditions

Atrial FibrillationCognitive Dysfunction

Interventions

WarfarinDabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPyridinesBenzimidazoles

Study Officials

  • Bruno Caramelli, Professor

    Heart Institute, University of Sao Paulo, Brazil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Cardiology

Study Record Dates

First Submitted

November 9, 2013

First Posted

November 25, 2013

Study Start

November 7, 2014

Primary Completion

March 9, 2021

Study Completion

March 9, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

BR(2)