Active Surveillance Research Program for the Assessment of the Safety and the Effectiveness of Linagliptin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189,426
- 试验地点
- 1
- 主要终点
- Number of Participants With Acute Coronary Syndrome
研究概览
简要总结
This protocol is for a series of comparative effectiveness and safety analyses within periodically updated cohorts of patients initiating linagliptin, other DPP-4 inhibitors, and other oral hypoglycemic medications, followed longitudinally for the occurrence of a variety of health outcomes. The primary analysis will be conducted among patients without prior within-class medication use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Acute Coronary Syndrome
时间窗: Up to 5 years and 7 months
Number of participants with acute coronary syndrome (ACS). The definition for ACS included acute myocardial infarction (MI), but acute MI was not assessed separately.
Number of Participants With Coronary Revascularization
时间窗: Up to 5 years and 7 month
Number of participants with coronary revascularization (elective and non-elective procedure)
Number of Participants With Stroke
时间窗: Up to 5 years and 7 months
Number of participants with ischemic or hemorrhagic stroke. Both types of stroke were included in the definition for stroke, but were not assessed separately
Number of Participants With Major Adverse Cardiovascular Event
时间窗: Up to 5 years and 7 months
Number of participants with major adverse cardiovascular event is presented by the number of patients reported a composite of: * Coronary revascularization (elective and non-elective procedure) * Acute coronary syndrome (ACS), including acute myocardial infarction (MI) * Stroke (Ischemic and hemorrhagic stroke)
次要结局
- Number of Participants With Acute Renal Failure(Up to 5 years and 7 months)
- Number of Participants With Incident End Stage Renal Disease(Up to 5 years and 7 months)
- Number of Participants With Acute Renal Failure Requiring Dialysis(Up to 5 years and 7 months)
- Number of Participants With Heart Failure Hospitalization(Up to 5 years and 7 months)