NCT02975453已完成不适用
Study of Risk Factors of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With a Direct Oral Anticoagulant (Rivaroxaban)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 1,481
- 主要终点
- 2MACE score
研究概览
简要总结
Evaluation of the performance of the 2MACE index in a population of nonvalvular atrial fibrillation (NVAF) patients treated with rivaroxaban in Spain
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years or older.
- •Patients with diagnosis of NVAF.
- •Patients treated with rivaroxaban from at least six months prior to the study inclusion.
- •Patients who have been given appropriate information about the study objectives and procedures and who have given their written informed consent.
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice.
- •Patients who initiate treatment with rivaroxaban after the start of the study inclusion period.
- •Prosthetic heart valves or the presence of any severe valvulopathies.
- •Patients with severe cognitive impairment.
- •Patients with chronic infections (HIV infection, hepatitis C virus, hepatitis B virus) or systemic autoimmune diseases.
- •Patients with active cancer.
- •Patients with liver insufficiency (eg. cirrhosis).
研究组 & 干预措施
Rivaroxaban
Non-valvular atrial fibrillation (NVAF) patients treated with rivaroxaban for at least 6 months prior to the study inclusion
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
结局指标
主要结局
2MACE score
时间窗: At baseline
MACE: Major adverse cardiovascular events. 2MACE: History of Myocardial infarction/ Cardiac revascularization and Metabolic Syndrome, Age \>75 years, Congestive heart failure (ejection fraction \<40%), Thrombo-Embolism
Occurrence of MACE to evaluate the performance of the 2MACE index
时间窗: At 2 years and 6 months or early termination
Percentage of patients with MACE including fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death
次要结局
- Incorporation of additional risk factors to the 2MACE index or replacing some of the existing ones(At baseline)
- Occurrence of stroke(At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination)
- Thromboembolic risk based on the CHA2DS2-VASC(At baseline)
- Occurrence of transient ischemic attack (TIA)(At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination)
- Occurrence of systemic embolism(At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination)
- Thromboembolic risk based on the CHADS2 score(At baseline)
- Patients' profile(At baseline)
- Occurrence of major cardiovascular events (fatal/nonfatal myocardial infarction, cardiac revascularization and cardiovascular death)(At baseline, at 1 year, at 2 years, at 2 years and 6 months or early termination)
- Number of MACEs occurring during the study(At 1 year, at 2 years, at 2 years and 6 months or early termination)
- Number of cases (frequency) of metabolism syndrome at enrollment with/without the occurrence of myocardial infarction or coronary revascularization(At baseline)
研究者
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