NL-OMON53411已完成不适用
A Multicenter, Cross-sectional Study to Characterize the Distribution of Lipoprotein(a) Levels Among Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD) - 20210057
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 1,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •101. Subject has provided informed consent prior to initiation of any study
- •specific activities/procedures.
- •102. Age 18 to 85 years.
- •103. History of ASCVD as demonstrated by either:
- •a) MI (presumed type 1)
- •b) PCI (with high-risk features) with at least 1 of the following:
- •- Age > 65 years
- •-Diabetes mellitus
- •- History of ischemic stroke
- •- History of peripheral arterial disease
- •- Residual stenosis >= 50%
- •- Multivessel PCI (ie, >= 2 vessels, including branch arteries)
- •See section 5.1 of the protocol.
排除标准
- •201. Subjects known to be currently receiving investigational drug in a
- •clinical study that is anticipated to last > 1 year
- •202. Known Lp(a) value < 90 mg/dL (if measured in mass) or < 200 nmol/L (if
- •measured in molar).
- •203. Subject has a diagnosis of end-stage renal disease or requires dialysis
- •204. Poorly controlled (glycated hemoglobin [HbA1c] > 10%) diabetes mellitus
- •(type 1 or type 2).
- •205. Subject is receiving or has received lipoprotein apheresis to reduce Lp(a)
- •within 3 months prior to enrollment.
- •206. Known uncontrolled or recurrent ventricular tachycardia in the past 3
- •months prior to enrollment.
- •207. Known malignancy (except non-melanoma skin cancers, cervical in situ
- •carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma)
- •within the last 5 years prior to enrollment.
- •208. Known history or evidence of clinically significant disease (eg,
- •respiratory, gastrointestinal, or psychiatric disease) or unstable disorder or
- •biomarker that, in the opinion of the investigator(s), would result in life
- •expectancy < 5 years.
- •209. Known hemorrhagic stroke.
- •See section 5.2 of the protocol.
研究者
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