Prospective, Randomized, Open-label, Blinded Endpoints, Multi-center Study to Evaluate the Efficacy of Modest Blood Pressure Reduction With Diovan® (Valsartan) in Acute Ischemic Stroke
试验速览
- 阶段
- 4 期
- 入组人数
- 578
- 试验地点
- 1
- 主要终点
- Death or dependency measured as functional status with the use of mRDs
研究概览
简要总结
The manipulation of blood pressure in acute cerebral ischemia has been a matter of debate until now. The investigators are clearly in need of more detailed data on how antihypertensive treatment affects outcome in acute phase of stroke.
This study will assess the effects of modest blood pressure (BP) lowering manipulation in acute period of ischemic stroke on death or dependency at 90-day.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •Patients admitted within 24 hours and can be enrolled within 48 hours after qualifying ischemic stroke onset
- •Patients with systolic blood pressure above 150 mm Hg and no more than 185 mm Hg at least twice of 3 or more times at 5 minutes intervals after resting
- •Baseline NIHSS score at least 2 points, not more than 21 points
- •Full functional independence prior to the present stroke indicated by an estimated premorbid mRS score of 0 or 1
- •Informed consent from the patients or authorized representatives must be obtained in writing enrollment into the study
排除标准
- •Patients who received thrombolytic therapy (intravenous or intraarterial)
- •Patients with acute Intracerebral hemorrhage diagnosed by neuroimaging
- •Patients with moderate or severe cardiac failure (New York Heart Association class III and IV)
- •Patients with medical condition which need urgent or special antihypertentive therapy, such as hypertensive encephalopathy, aortic dissection, acute renal failure, acute pulmonary edema, or acute myocardial infarction
- •Comatose at screening
- •Known or suspected cerebral aneurysm or arteriovenous malformation
- •Any other clinical relevant serious disease, including uncontrolled Diabetes, severe liver disease, or severe renal disease at the time of randomization
- •Life expectancy of less than 3 months due to comorbid conditions, such as malignancy
- •Participation in another drug trials or planned use of vascular interventions within the previous 30 days
- •Women who are pregnant, breast feeding, or of child bearing potentials
- •Contraindication to ARBs, such as history of angioedema to ARBs, renovascular hypertension
研究组 & 干预措施
valsartan group
The valsartan group will be initially given 80 mg of Diovan® (valsartan) per oral once daily in the morning on day 1, and flexibly will be adjusted to a dose of 80 -320 mg per day during next 6 days if more than 30% of SBPs measured at least 4 times in a day will not get the target level of SBPs.
干预措施: Diovan® (valsartan) (Drug)
结局指标
主要结局
Death or dependency measured as functional status with the use of mRDs
时间窗: 90 days after the onset
次要结局
- NIHSS(7 days and 90 days after stroke onset)