Effect of Rosuvastatin on Outcome by NIHSS After Intracerebral Hemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- NIHSSº
研究概览
简要总结
The purpose of this study is to determine whether rosuvastatin is effective in the management of acute phase of intracerebral hemorrhage and if it impact outcome by NIHSS.
详细描述
The intracerebral hemorrhage (ICH) is a frequent problem of health, with high morbid-mortality. In addition it originates expensive expenses in health care systems.
ICH produces damage by mass effect, then by biochemical ways which are activated and they carry to secondary damage. Many studies have been conducted for explaining secondary injury, now we know there are ischemic changes related maybe with changes in cerebral flow and metabolism, in addition to activate inflammatory ways. Many drugs and measures has been ineffective for getting best outcome, without success.
Statins or inhibitors of HMG CoA reductase are drugs used in dyslipidemia, frequently for reduction in LDL. Experimental and clinical studies in stroke and ICH have shown improvement in outcome. The toxicity related to statin is myopathy and hepatopathy, both with low incidence without fatal cases. Rosuvastatin has been postulated be the most powerful with longest life and toxicity similar to another statins.
We have designed this study to demonstrate if the administration of rosuvastatin in the first 24 hours and by 14 days has improvement in outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or Women >16 and < 80 years with ICH and hospital attention in less 24 hours
- •Confirmation by CT scan
- •Acceptance by family
排除标准
- •History of stroke
- •History of neurological disease, head injury o psychiatric disorder with disability
- •Glasgow less than 9
- •Administration 24 hours before: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem, amiodarone.
- •Use before hospital of: mannitol, barbiturates, corticosteroids, calcium antagonists
- •Any lesion which needs surgery
- •Allergy to drug used
- •cerebral death
- •Hepatic disease (Child B y C) or myopathy (or) history
- •Management in other Hospital
- •Pregnancy
- •ICH major than 60 ml.
- •hypothyroidism
研究组 & 干预措施
B
A, Active B, Historical Register
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
NIHSSº
时间窗: basal and discharge
次要结局
- Survivor(within 1 month)