A Multicenter Prospective Observational Double Cohort Study to Evaluate the Associations Between Clinical Characteristics and Use of Oral Anticoagulants in Italian Elderly Patients Suffering From NVAF.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 636
- 试验地点
- 2
- 主要终点
- Anticoagulant (OA) cohort: Distribution of participants starting any type of anticoagulant direct-acting oral anticoagulant (DOAC) or Vitamin K antagonist (VKA) treatment
研究概览
简要总结
The purpose of this study is to provide real-world data useful to address the factors associated to the administration of oral anticoagulants in the elderly population affected by non-valvular atrial fibrillation (NVAF), in Italy, and it's persistence rate after one year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- •Inclusion Criteria:
- •Diagnosis of any type (e.g. persistent, permanent, paroxysmal) of Non-Valvular Atrial Fibrillation (NVAF) documented in the participant's medical chart based on electrocardiogram (ECG) results, or diagnosed at enrollment
- •Naïve to anticoagulant treatments, or not having received anticoagulant treatments during the 6 months prior to enrollment
- •Multidimensional geriatric assessment (MGA) performed at enrollment, or anyway no more than 3 months before in case of stable disease (i.e. no relevant events) in the previous 3 months
排除标准
- •Valvular atrial fibrillation (AF) due to artificial heart valve
- •Medical conditions (apart from NVAF) requiring anticoagulant therapy (such as deep vein thrombosis or pulmonary embolism)
- •Use of inappropriate direct-acting oral anticoagulant (DOAC) doses based on the current summary of product characteristics (SmPC) for any drugs
结局指标
主要结局
Anticoagulant (OA) cohort: Distribution of participants starting any type of anticoagulant direct-acting oral anticoagulant (DOAC) or Vitamin K antagonist (VKA) treatment
时间窗: At Enrollment, up to 12 months
Non-Anticoagulant (Not-OA) cohort: Distribution of participants not starting any type of anticoagulant (DOAC) or (VKA) treatment
时间窗: At Enrollment, up to 12 months
Distribution of participants with persistence to the first treatment strategy: No switches nor interruptions of greater than 60 days in the first administered antithrombotic strategy (including no treatments) during the 12-month observational period
时间窗: Up to approximately 12 months
Treatment switch: Change of antithrombotic drug (in terms of active principle) during the 12-month observational period
时间窗: Up to approximately 12 months
Distribution of participants with net clinical outcomes defined as occurrence of stroke, systemic embolism, major bleeding or death
时间窗: Up to approximately 12 months
次要结局
未报告次要终点