ATIVO Study - Anticoagulation Therapy in the Very Old
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Number of Patients Experiencing a Major Bleeding Event
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of warfarin anticoagulation in the very old and attempt to identify risk factors which may impede safe and effective anticoagulation.
详细描述
This is a prospective registry study with data being collected continuously for 24 months.
Patients who have electrocardiographically confirmed atrial fibrillation, are being followed by the Pen Bay Medical Center Anticoagulation Services and are at least 90 years old will be recruited into the study. A matched cohort of patients between the ages of 80 and 89 and another matched cohort of patients between the ages of 70 and 79 will also be recruited into the study for comparison.
Data related to adverse events, concomitant medications, living arrangements, mobility and alcohol use will be collected every 6 months. In addition the CHA2DS2-VASc (score for atrial fibrillation stroke risk), HAS - BLED (major bleeding risk score for patients on anticoagulation), frailty and Mini Cog scores will be recalculated at each visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •70 years of age or older
- •electrocardiographically confirmed atrial fibrillation
- •anticipated regular follow up with patient by Penobscot Bay Medical Center (PBMC) Anticoagulation Services
- •Subject or legally authorized representative must be willing to provide informed consent
排除标准
- •Patients not being followed by the PBMC Anticoagulation Services
研究组 & 干预措施
Aged 90 and older
Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
干预措施: Warfarin (Drug)
Aged 80-89
Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
干预措施: Warfarin (Drug)
Aged 70-79
Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
干预措施: Warfarin (Drug)
结局指标
主要结局
Number of Patients Experiencing a Major Bleeding Event
时间窗: 24 months
defined as one of the following: fatal bleeding, symptomatic bleeding in a critical area or organ or bleeding causing a fall in hemoglobin of 2 g/dl or more or leading to a transfusion of 2 or more units of whole blood or red cells
Number of Patients Experiencing Stroke
时间窗: 24 months
Every 6 months the medical record was reviewed for evidence of stroke of any cause.
次要结局
- Number of Patients Experiencing a Traumatic Subdural Hemorrhage(24 months)
- Number of Patients Experiencing Death Related to Anticoagulation(24 months)
- Number of Patients Experiencing Cardiovascular Death(24 months)
- Number of Hospitalizations Patients Experienced(24 months)
- Mean Time in Therapeutic Range at End of Study Participation(up to 24 months)
- Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage(24 months)
研究者
Robert Stein
Medical Director of Anticoagulation Services
MaineHealth