Randomized Trial of Apixaban vs Dose Adjusted Warfarin in Reducing Rate of Cognitive Function Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Non-valvular Atrial Fibrillation Patients With CHA2DS2-VaSc Score = 2
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- MRI Evidence of New Cerebral Micro-bleeds
研究概览
简要总结
The investigators' central hypothesis is that in patients with atrial fibrillation, anticoagulation with Apixaban reduces the rate of decline in cognitive function, when compared to Warfarin. The investigators also hypothesize that Apixaban reduces cognitive decline by reducing the rate of new cerebral infarction and cerebral microbleeds detected by cerebral MRI compared to warfarin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-valvular Atrial Fibrillation
- •CHA2DS2-VASc Score > or = to 2
- •Never been treated with Apixaban (Eliquis) or prior treatment of < 1 month
- •Candidate for oral anticoagulation as assessed by a treating physician
排除标准
- •Valvular Atrial Fibrillation (Rheumatic valve disease,Moderate or greater mitral stenosis,Mechanical cardiac valve)
- •Active Bleeding
- •Prior treatment with Apixaban >1 month
- •Recent stroke within 7 days
- •Implanted devices not compatible with MRI/any cardiac implanted device
- •Claustrophobia
- •Active alcohol/drug abuse
- •Life expectancy < 1 year
- •Taking asprin with >100mg doses
- •Known hypersensitivity to warfarin or Apixaban
- •Severe renal insufficiency
- •Prior severe bleeding (Intracranial bleeding (subdural, subarachnoid, intraparenchymal bleeding),GI bleed requiring transfusion,Bleeding from other sites requiring transfusion)
- •Psychosocial reasons that make study participation impractical
- •Currently enrolled in another IND or IDE trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- •Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or that could impact the scientific integrity of the study.
- •Prisoners or subjects who are involuntarily incarcerated
- •Subjects who are compulsorily detained for treatment of either psychiatric or physical illness
- •Current or expected systemic treatment with strong dual inhibitors of CYP3A4 and P-gp (Any one of rifampin, carbamazepine, phenytoin, St. John's Wort, ketoconazole, itraconazole, ritonavir, clarithromycin)
- •Need for dual anti-platelet therapy with aspirin and another agent such as thienopyridine
研究组 & 干预措施
Eliquis
干预措施: Apixaban (Drug)
Warfarin
干预措施: Warfarin (Drug)
结局指标
主要结局
MRI Evidence of New Cerebral Micro-bleeds
时间窗: Baseline, Year 2
Magnetic Resonance Imagining of the brain to assess the development of new cerebral micro-bleeds
Standardized Neurocognitive Function Score
时间窗: Baseline, Year 1, Year 2
Assess the change in cognitive function using standardized neurocognitive assessment.
MRI Evidence of Silent Cerebral Infarct
时间窗: Baseline, Year 2
Magnetic Resonance Imagining of the brain to assess the development of new silent cerebral infarcts.
次要结局
未报告次要终点
研究者
Malini Madhavan
Principal Investigator
Mayo Clinic