NCT02041117已完成4 期
Resuvastatin Treatment for Symptomatic Middle Cerebral Artery Stenosis Based on High-resolution Magnetic Resonance Imaging in Two Years
Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2014年2月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- The change in the percentage of volume of MCA atherosclerosis plaque after 2 years treatment of Rosuvastatin 10-20mg
研究概览
简要总结
- It is a multicenter, open-label, sing arm study to evaluate the effects of treatment of Rosuvastatin 10-20mg in volume and morphology of atherosclerotic plague by reducing LDL-C level to or less than 70mg/dl.
- Ischemic stroke patients will be enrolled within 1 month after stroke onset.
- Patients will be visited at 0m, 1m, 3m, 6m, 9m, 12m, 18m and 24m.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients between 18 and 75 years of age.
- •Ischemic stroke originate from middle cerebral artery(MCA) AS stenosis, stroke onset within 1 month.
- •LDL-C level is more than 70mg/dl (1.8mmol/L), but less than 250mg/dl (6.5mmol/L); and triglyceride level is less than 353mg/dl (4.0mmol/L).
- •total term of statin therapy less than 2 month in past 1year before entering the study.
- •（5）30-70% intracranial artery stenosis in M1 segment of MCA comfirmed by CTA or MRI at least 1 or more atherosclerotic plaques in M1 segment of MCA is detectable.
- •（6）Female patients must agree to use an effective form of birth control throughout the 2-year study treatment period.
- •（7）The patients who are willing to be enrolled have to remain on the low cholesterol dietary for the study duration.
- •（8）The patient must be able to comply with scheduled visits, the treatment plan and all laboratory tests.
- •（9）Written informed consent is provided to participate in the study.
排除标准
- •Any hemorrhagic stroke or hemorrhagic infarction
- •Presence of any of cardiac sources of embolism
- •Ischemic stroke caused by non MCA stenosis
- •The patients has LDL cholesterol ≤ 70mg/dl or familial hypercholesterolemia.
- •Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform staged angioplasty within 2 years
- •Any aneurysm proximal to or distal to stenotic intracranial artery
- •Intracranial tumor (except meningioma) or any intracranial vascular malformation
- •Thrombolytic therapy within 24 hours before enrollmentnt
- •The patient has plans for surgical/endovascular intervention for intracranial, carotid, coronary and/or peripheral arterial disease during the course of the study.
- •The patient has or is being treated or evaluated for diagnosed tuberculosis.
- •The patient has a history of malignant neoplasm within the previous 5 years (exception: curable non-melanoma skin malignancies).
- •The patient has a known immunodeficient state (e.g., human immunodeficiency virus) or is being treated with immunosuppressive drugs including cyclosporine.
- •The patient has any other clinically significant medical condition that, in the opinion of the Investigator, could impact the patient's ability to successfully complete the trial.
- •Life expectancy of patients is less than 2 years.
- •The patient have to take medicines as follow: Hormonal therapy, Cyclosporine and other lipid lowering agents: fish oil, garlic essential oil etc.
- •The patient has a history of recent alcohol abuse, drug abuse or significant mental illness.
- •The patient has any condition that would prevent the patient from giving voluntary informed consent.
- •The patient has an inability to tolerate oral medication administration.
- •The patient has a known or suspected allergy to the study medication(s) or the class of study medication to be administered.
- •The patients cannot finish HR-MRI for any reasons.
- •Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study
- •The patient is enrolled or plans to enroll in another clinical drug or device/interventional trial during this study.
- •The patient has the history of epilepsy/seizures.
- •The patient has liver function tests > 1.5 times the upper limit of normal, serum creatinine > 2.0 mg/dL, GFR < 30 ml/min or has abnormal laboratory values which are deemed clinically significant by the investigator.
- •The patient has the history of myopathy.
- •The patient has thyroid stimulating hormone > 1.5xULN.
- •BMI ≥ 30 kg/m2
研究组 & 干预措施
Rosuvastatin
Other
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
The change in the percentage of volume of MCA atherosclerosis plaque after 2 years treatment of Rosuvastatin 10-20mg
时间窗: 2 year
次要结局
- The change in Percentage of plaque volume of M1segment plaque(6 months and 1 year)
- The change in percentage of thickness of fibrous cap(2 years)
- The change in percentage of intraplaque hemorrhage(2 years)
- Moderate bleeding (GUSTO definition)(2 years)
- Intracranial hemorrhage(2 years)
- Total mortality(2 years)
- AEs/SAEs reported by the investigators(2 years)
- The change in Percentage of lumen volume(2 years)
- The change in percentage of lipid rich necrotic core(2 years)
- Recurrency of stroke or TIA(2 years)
- The change of percentage in LDL-C from baseline(2 years)
- The change in HDL-C level from baseline(2 years)
- To explore the relationship between the change of plaque volumn and morphology and the change in LDL-C, HDL-C and Hs-CRP level(2 years)
- safety-Rhabdomyolysis，Hepatonecrosis(2 years)
- The change in hsCRP level from baseline(2 years)
- 2.Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage(2 years)
- Incidence symptomatic and asymptomatic intracranial hemorrhagic events at 3 months(2 years)
研究者
Yongjun Wang
Executive Vice-President
Beijing Tiantan Hospital
研究点 (1)
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