Randomized Clinical Trial for the Prevention of Cognitive Impairment in Atrial Fibrillation Patients Treated With Dabigatran or Warfarin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Cognitive impairment
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atrial fibrillation
- •CHA2DS2-VASc Score for Atrial Fibrillation Stroke Risk (CHADS2VASc) greater than 1
排除标准
- •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%
研究组 & 干预措施
Warfarin
Treatment with Warfarin once daily, taken at fast, to maintain INR between 2 and 3.
干预措施: Warfarin (Drug)
Dabigatran
Dabigatran 150 mg twice daily
干预措施: Dabigatran (Drug)
结局指标
主要结局
Cognitive impairment
时间窗: Two years
Cognitive impairment at two years, independently of stroke or other cerebrovascular events.
次要结局
- Number of Participants with less important alteration in coagulation test as a Measure of Safety(Two years)
研究者
Bruno Caramelli
Associate Professor of Cardiology
University of Sao Paulo