EUCTR2009-016737-95-IT进行中（未招募）不适用
ROSuvastatin Pretreatment to Reduce Embolization during Carotid Artery Stenting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Carotid stenosis =80% at ultrasound in asymptomatic patients; - Male and female; - Age between 18 and 80 years; - No contraindications to CAS (major functional or cognitive impairment; inability to achieve safe vascular access; extreme carotid lesion calcification; visible thrombus in lesion; long subtotal occlusion (string sign); life expectancy <5 years; contraindication to aspirin or thienopyridines; severe renal dysfunction precluding safe contrast medium administration). - Baseline LDL >120 mg/dL and/or baseline CRP level > 4 mg/dL. -Informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •- Baseline LDL =120 mg/dL and CRP level = 4 mg/dL. - Impossibility to use embolic protection. - Recent (<3 months) neurologic symptoms (cerebral or ocular ischemia ipsilateral to the carotid stenosis to be treated with CAS) requiring intervention on the carotid artery without delay. - Treatment with any statin within 6 months before the time of screening;- Active internal bleeding. - Recent cranial or spinal trauma or surgery (within 2 months). - Recent gastroenteric or genitourinary bleeding (within 6 weeks) of clinical significance. - Haemorrhagic diathesis- - Thrombocitopenia (<100.000 PLT/ml). - Severe uncontrolled arterial hypertension. - Intracranial neoplasm or arteriovenous malformation or aneurysm. - Contraindication to aspirin and/or thienopyridines. -Pregnancy and lactation. - Women in fertile age or women who do not satisfy the following definition of postmenopause: physiological amenorrhoea dating >12 months or bilateral ovariectomy dating > 6 weeks (in the case of single ovariectomy the reproductive state must be assessed by hormonal determination). -Hypersensitivity to rosuvastatin or to any of the excipients. - Active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 x the upper limit of normal (ULN). Moderate to severe renal impairment (creatinine clearance <60 ml/min). - Myopathy. - Concomitant use of ciclosporin, fibrates, or vitamin K antagonists. - Hypothyroidism. - Personal or family history of hereditary muscular disorders. - Previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate. - Alcohol abuse.
研究者
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