NCT02341794Unknown不适用
Rosuvastatin Treatment for Intracranial Arterial Stenosis Based on Magnetic Resonance Angiography
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression of intracranial arterial stenosis after two years
研究概览
简要总结
The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis.
详细描述
The purpose of this study is to investigate the effects of rosuvastatin treatment on degree of intracranial arterial stenosis in two years. Dyslipidemia patients with intracranial arterial stenosis will be enrolled under informed consent in this study. Rosuvastatin (5mg) will be orally administered once daily. Dose of rosuvastatin will be adjusted to control serum LDL-c level under 1.8mmol/L. Primary outcome is the progression of intracranial stenosis on magnetic resonance angiography (MRA) after two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients between 30 and 80 years of age.
- •Patients with noncardioembolic ischemic stroke
- •Patients with intracranial arterial stenosis ≥50% in supraclinoid internal carotid artery, M1 portion of middle cerebral artery, A1 portion of anterior cerebral artery, P1 portion of posterior cerebral artery, or basilar artery.
- •LDL-C level is more than 100 mg/dl (2.6 mmol/L) or under treatment of dyslipidemia
- •Patients taking clopidogrel as antiplatelet therapy when providing informed consent
- •Patients considered to be able to visit the study site
- •Patients who provided written informed consent
排除标准
- •Any haemorrhagic stroke or haemorrhagic infarction
- •Familial hypercholesterolemia
- •Patients with uncontrolled angina pectoris or congestive heart failure
- •Patients with severe liver or renal dysfunction
- •Patients with a malignant tumor requiring treatment
- •Patients with uncontrolled diabetes mellitus
- •Patients with secondary dyslipidemia (due to corticosteroid etc)
- •Patients with a history of myopathy
- •Patients considered by the investigator to be unsuitable for participating in this study
研究组 & 干预措施
Rosuvastatin
Experimental
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Progression of intracranial arterial stenosis after two years
时间窗: 6 months, 1 year and 2 years
次要结局
- Any stroke (ischemic stroke, intracerebral haemorrhage, subarachnoid haemorrhage)(6 months, 1 year and 2 years)
- Ischemic stroke or transient ischemic attack(6 months, 1 year and 2 years)
- Intracerebral haemorrhage or subarachnoid haemorrhage(6 months, 1 year and 2 years)
- Death from any cause(6 months, 1 year and 2 years)
- Cardiovascular events (ischemic stork, cardiac infarction, and other vascular events(6 months, 1 year and 2 years)
- The change of percentage in LDL-C from baseline(6 months, 1 year and 2 years)
- The change in HDL-C level from baseline(6 months, 1 year and 2 years)
- Intracranial haemorrhage(6 months, 1 year and 2 years)
- Number of cerebral microbleeds on MRI(6 months, 1 year and 2 years)
- Carotid intima-media thickness(6 months, 1 year and 2 years)
- Ankle brachial index(6 months, 1 year and 2 years)
- Brachial-ankle pulse wave velocity(6 months, 1 year and 2 years)
- Adverse events and adverse drug reactions(up to 2 years)
研究者
研究点 (1)
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