Randomized Controlled Trial of Early Versus Late Statin Therapy in Patients With Ischemic Stroke
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- modified Rankin Scale
研究概览
简要总结
Investigators will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection
详细描述
It is much more important in Japan than Western to improve the prognosis after stroke because the prevalence and mortality rate of stroke in Japan is about 3-4 times as those of acute myocardial infarction. Investigators will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection since most of previous studies with statins just showed the preventive effects from onset of primary or recurrent cerebral infarction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the Informed consent will be acquired by the document.
- •Age: 20 years of age or older.
- •Gender: unquestioned
- •hospitalization, outpatient: hospital
- •Patients by MRI at the time of hospital transport, it has been confirmed diagnosed with cerebral infarction
- •ingestible in within 24 hours after admission In the study treatment period, patients that can be defined treatment in this clinical study implementation plan
排除标准
- •patients with a history of hypersensitivity to the treatment agent of the present study
- •Patients acute hepatitis, chronic hepatitis acute exacerbation, liver cirrhosis, it is believed that the liver cancer, liver function jaundice or the like is reduced, or a biliary obstruction
- •Patients suspected of being pregnant or pregnant
- •Patients in the administration of the cyclosporine or telaprevir
- •patients with moderate or severe renal impairment (SCr ≧ 2.5mg / dL or eGFR <30mg / dL)
- •Patients who received a diagnosis of acute coronary syndrome within 6 months
- •valvular disease, atrial fibrillation, patients with atrial thrombus
- •Patients familial hypercholesterolemia
- •patient admission NIHSS score is greater than or equal to 3 is more than 20 or before the onset mRS score
- •patients with other doctors deemed inappropriate
研究组 & 干预措施
Acute Group
Atorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment initiated within 24 hours after admission
干预措施: Statin (Drug)
Stable Group
Not start or withdraw Atorvastatin 20 mg or Pitavastain 4 mg or Rosuvastatin 5 mg treatment for a weak after admission.
干预措施: Statin (Drug)
结局指标
主要结局
modified Rankin Scale
时间窗: 12 weeks from stroke onset
Scale range from 0 \[no symptom\] to 6 \[dead\]
次要结局
未报告次要终点
研究者
Shinichi Yoshimura
Principal Investigator
Hyogo Medical University