CTRI/2014/01/004324已完成3 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When evolocumab is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease - FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk)
Amgen Technology Pvt Ltd0 个研究点目标入组 266 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 266
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
入选标准
- •1. Male or female >= 40 to <= 85 years of age {Note: For India the upper age will be limited to 80yrs as per DCGI approval letter}
- •2. History of clinically evident cardiovascular disease at high risk for a recurrent event
- •3. Fasting LDL-C >= 70 mg/dL (>= 1.8 mmol/L) ) or non-HDL-C >= 100 mg/dL ( > 2.6 mmol/L)
- •4. Fasting triglycerides <= 400 mg/dL (4.5 mmol/L)
排除标准
- •1. NYHA class III or IV, or last known left ventricular ejection fraction less than 30%
- •2. Uncontrolled hypertension
- •3. Uncontrolled or recurrent ventricular tachycardia
- •4. Untreated hyperthyroidism or hypothyroidism
- •5. Homozygous familial hypercholesterolemia
- •6. LDL or plasma apheresis
研究者
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