Cognitive Impairment Related to Atrial Fibrillation Prevention Trial

Atrial Fibrillation Clinical Trial

— GIRAF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994265
• Other study ID #: USP/UFMG 2013
• Status: Completed
• Phase: Phase 4
• Start date: November 7, 2014
• Est. completion date: March 9, 2021

Study information

• Verified date: September 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 9, 2021
• Est. primary completion date: March 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cognitive Dysfunction

Intervention

Drug:
• Warfarin
Warfarin once daily, at fast, targeting INR between 2 and 3
• Dabigatran

Locations

Country	Name	City	State
Brazil	Federal Univeristy of Minas Gerais	Belo Horizonte	Minas Gerais
Brazil	Heart Institute - University of São Paulo	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Boehringer Ingelheim, Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive impairment	Cognitive impairment at two years, independently of stroke or other cerebrovascular events.	Two years
Secondary	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.	Two years