NL-OMON48805已完成3 期
High-Resolution Assessment of Coronary Plaques in a Global Evolocumab Randomized Study (HUYGENS) - 20160184 HUYGENS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 43
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •*Clinical indication for coronary angiography during admission due to non ST
- •segment elevation acute coronary syndrome (NSTE-ACS) with interventional
- •treatment of culprit plaque.
- •*Subjects must have an eligible LDL-C level via local laboratory assessment in
- •between admission for ACS and coronary angiogram.
- •*Subject must be on optimal statin therapy per local guidelines prior to
- •randomization.
- •*Subjects must meet all of the criteria at the qualifying coronary angiogram
排除标准
- •*Subject has taken a cholesterol ester transfer protein (CETP) inhibitor,
- •(i.e., anacetrapib, dalcetrapib, evacetrapib), mipomersen , lomitapide or has
- •undergone LDL apheresis in the last 12 months prior to LDL-C screening
- •*Subject has previously received evolocumab or any other therapy to inhibit
- •*Baseline OCT does not meet OCT imaging criteria as determined by the Core Lab
- •technical standards.
研究者
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