JPRN-UMIN000001029未知未知
Carotid plaque in Human for ALL Evaluations with Aggressive Rosuvastatin Therapy: Evaluation by Magnetic Resonance Imaging - CHALLENGER trial
Juntendo University School of Medicine0 个研究点目标入组 50 人开始时间: 2008年2月15日最近更新:
试验速览
- 阶段
- 未知
- 发起方
- 入组人数
- 50
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients currently receiving other lipid-lowering drugs apart from the test drug. 2) Patients who have received any HMG-CoA reductase inhibitor (statin) within 3 months before the observation period. 3) Patients with severe carotid stenosis and marked calcification. 4) Patients with the fasting TG level of more than 400 mg/dL. 5) Patients with uncontrolled hypertension (DBP100mmHg or SBP200mmHg throughout the observation period). 6) Patients with familial hypercholesterolemia that cannot be controlled by statin therapy. 7) Patients with secondary hyperlipidemia due to thyroid dysfunction, Cushing's syndrome, nephrotic syndrome, systemic lupus erythematosus, etc. 8) Patients receiving LDL apheresis. 9) Patients on treatment with cyclosporine. 10) Patients with renal dysfunction or on hemodialysis. 11) Patients with a history of severe adverse effects or allergy to statins. 12) Patients with confirmed malignancy, possible malignancy, or a history of malignancy. 13) Patients with active liver disease or hepatic dysfunction (ALT, AST, ALP levels more than 2.5 times the upper limit of normal, or a total bilirubin of more than 3.0 mg/dL). 14) Patients with the serum creatinine of more than 1.5 mg/dL. 15) Patients with the serum creatine kinase (CK) level at least 3 times the upper limit of normal. 16) Patients with contraindications to MRI. 17) Patients cannot be taken their MRI pictures. 18) Patients who are ineligible for any other reason in the opinion of the investigator.
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