Cognitive Impairment Related to Atrial Fibrillation Prevention Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-07

Study Completion Date

2021-03-09

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Warfarin

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

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

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

Dabigatran

Dabigatran 150 mg twice daily

Group Type ACTIVE_COMPARATOR

Dabigatran

Intervention Type DRUG

Interventions

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Warfarin

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

Intervention Type DRUG

Dabigatran

Intervention Type DRUG

Other Intervention Names

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Marevan, Coumadin Dabigatran 150 mg twice daily

Eligibility Criteria

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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%

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No