Cognitive Impairment Related to Atrial Fibrillation Prevention Trial

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01994265

Acronym

GIRAF

Enrollment

200

Registered

2013-11-25

Start date

2014-11-07

Completion date

2021-03-09

Last updated

2021-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Cognition, Cognitive impairment, Anticoagulation, Dabigatran, Warfarin, Efficacy

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).

Interventions

DRUGWarfarin

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

DRUGDabigatran

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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%

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026