Comparison of Peripheral and Cerebral Arterial Flow in Acute Ischemic Stroke: Fimasartan vs. Valsartan vs. Atenolol
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 105
- 主要终点
- Central Blood pressure control
研究概览
简要总结
Confirm central blood pressure reduction effect of Fimasartan, Valsartan and Atenolol and compare correlation with the measured peripheral (central blood pressure, pulse wave velocity, and flow-mediated dilation) and cerebral blood flow factors (transcranial doppler findings, cerebral blood flow volume) in acute ischemic stroke patients with hypertension.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 30 years old
- •Acute ischemic stroke patient who has corresponding DWI(diffusion- weighted imaging) lesion correlated with symptom
- •after 7days, but within 28days from stroke onset
- •Diagnosed with Hypertension
- •hypertensive patients who taking anti-hypertensive drugs or SBP≥140mmHg
- •Informed consent
排除标准
- •Patients with hemorrhagic Stroke
- •Patients with severe Stroke - over NIHss(National Institutes of Health stroke scale) 16
- •Uncontrolled hypertension (SBP ≥200mmHg)
- •Patients with history of allergic reaction to any angiotensin II antagonist
- •Liver disease(more than double to normal level, SGOT(serum glutamic-oxaloacetic transaminase ), SGPT(serum glutamic-pyruvic transaminase ), total bilirubin)
- •Renal disease(serum creatinine ≥2.0mg/dl)
- •Anemia(Hb < 8mg/dl)
- •Thrombocytopenia( < 10^3/ml)
- •Patients with secondary hypertension
- •Childbearing and breast-feeding women
- •Otherwise inappropriate patients depending on the investigator's decision
研究组 & 干预措施
Fimasartan
fimasartan potassium 60mg, 1 tablet by mouth, every day Angiotensin ll receptor blocker
干预措施: Fimasartan (Drug)
Valsartan
valsartan 80mg, 1 tablet by mouth, every day angiotensin II receptor antagonists
干预措施: Valsartan (Drug)
Atenolol
atenolol 50mg, 1 tablet by mouth, every day beta-blocker
干预措施: Atenolol (Drug)
结局指标
主要结局
Central Blood pressure control
时间窗: 12 weeks
次要结局
- Blood pressure at the brachial artery(12 weeks)
- Flow-mediated dilation (FMD)(12 weeks)
- Adverse Events(12 weeks)
- Cerebral blood flow (CBF) volume(12 weeks)
- Brachial-ankle pulse wave velocity (ba-PWV)(12 weeks)
- Pulsatile index (PI)(12 weeks)
研究者
Ji Man Hong
Associate Professor
Ajou University School of Medicine