Clinical trial NCT01994265: Cognitive Impairment Related to Atrial Fibrillation Prevention Trial
Official title: Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Cognition
Cognitive impairment
Anticoagulation
Dabigatran
Warfarin
Efficacy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Federal University of Minas Gerais
name: Boehringer Ingelheim
First posted: 2013-11-25
Enrollment: 200
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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%

Primary outcomes:
measure: Cognitive impairment
timeFrame: Two years
Secondary outcomes:
measure: Number of Participants with less important alteration in coagulation test as a Measure of Safety
timeFrame: Two years
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal Univeristy of Minas Gerais
state: Minas Gerais
city: São Paulo
country: Brazil
facility: Heart Institute - University of São Paulo
Study officials:
affiliation: Heart Institute, University of Sao Paulo, Brazil
name: Bruno Caramelli, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caramelli B, Yu PC, Cardozo FAM, Magalhaes IR, Spera RR, Amado DK, Escalante-Rojas MC, Gualandro DM, Calderaro D, Tavares CAM, Borges-Junior FA, Pastana AF, Matheus MG, Brucki SMD, Rodrigues ACO, Nitrini R, Caramelli P. Effects of dabigatran versus warfarin on 2-year cognitive outcomes in old patients with atrial fibrillation: results from the GIRAF randomized clinical trial. BMC Med. 2022 Oct 26;20(1):374. doi: 10.1186/s12916-022-02563-2.