Cognitive Impairment Related to Atrial Fibrillation Prevention Trial

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Dabigatran; Drug: Warfarin

• Registration Number: NCT01994265
• Lead Sponsor: University of Sao Paulo

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).

Study Timeline

• Study First Submitted: 2013-11-09
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-25
• Study Start: 2014-11-07
• Primary Completion: 2021-03-09
• Study Completion: 2021-03-09
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dabigatran	Dabigatran	Dabigatran 150 mg twice daily
Warfarin	Warfarin	Treatment with Warfarin once daily, taken at fast, to maintain INR between 2 and 3.

Primary Outcome Measures

Name	Time	Method
Cognitive impairment	Two years	Cognitive impairment at two years, independently of stroke or other cerebrovascular events.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Federal Univeristy of Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Heart Institute - University of São Paulo; 🇧🇷 São Paulo, Brazil