NCT03692234Unknown不适用
Homoarginine in Stroke (HiS) Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Homoarginine serum concentration
研究概览
简要总结
This study represents a follow-up of the previous study "Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects" (NCT02675660). This study will evaluate the applicability of an oral formulation of L-homoarginine to normalize homoarginine blood levels in patients with acute ischemic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •ischemic stroke (CT or MRI), high-risk transient ischemic attack (ABCD2-score >= 4) or acute central retinal artery occlusion
- •serum homoarginine </= 2.1 umol/L
- •signed informed consent
排除标准
- •no acute stroke
- •serum homoarginine > 2.1 umol/L
- •heart failure (NYHA > 1)
- •chronic kidney disease (GFR <60 mL/min)
- •not competent
- •pregnancy, lactation
- •no or withdrawn signed informed consent
结局指标
主要结局
Homoarginine serum concentration
时间窗: six month
Normalization of homoarginine serum concentration to levels \>2.1 umol/L.
次要结局
- Modified Ranking Scale(six month)
- National Institute of Health Stroke Scale(six month)
- Intima-media thickness(six month)
研究者
研究点 (2)
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