GIRAF: Cognitive Impairment Related to Atrial Fibrillation Prevention Trial

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01994265

Collaborator

Federal University of Minas Gerais (Other), Boehringer Ingelheim (Industry)

200

Enrollment

Locations

Arms

Duration (Months)

100

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Warfarin Drug: Dabigatran	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 7, 2014

Actual Primary Completion Date :

Mar 9, 2021

Actual Study Completion Date :

Mar 9, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Cognitive impairment [Two years]
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 [Two years]
Comparison of thrombin generation test between the two treatment groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts 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%