Olmesartan Versus Nebivolol in Management of Hypertension in Acute Ischemic Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Between-group difference in change of 24-hour brachial BP
研究概览
简要总结
Single-blind, randomized, active-treatment controlled clinical study evaluating the effect of omesartan and nebivolol versus no treatment on 24-hour brachial and central aortic blood pressure in hypertensive patients with acute ischemic stroke
详细描述
A total of 60 patients with hypertension and acute ischemic stroke (clinic BP >160/100 mmHg and <220/120 mmHg at day 3 of stroke onset) will be randomly allocated to therapy with olmesartan (20 mg/day) or nebivolol (5 mg/day) or no treatment between the 3rd to 7th day of hospitalization.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a first diagnosis of an acute ischemic stroke (permanent or transient)
- •BP levels >160/100mmHg at start of the third day of hospitalization
- •BP levels >160/100mmHg and <220/120mmHg at start of the fourth day of hospitalization
排除标准
- •Patients with confirmed hemorrhagic stroke with computer tomography at hospital admission.
- •Patients with chronic atrial fibrillation or other cardiac arrhythmia.
- •Patients with BP levels >220/120 mmHg during the hospitalization or patients with other hypertensive emergency situation (i.e. acute myocardial ischemia, aortic dissection, acute pulmonary edema, acute renal failure, hypertensive encephalopathy) which demands fast BP reduction with the use of intravenous antihypertensive drugs, according to current guidelines {Jauch, 2013 340 /id}.
- •Patients with specific indication for treatment with blockers of the renin-angiotensin-aldosterone system (RAAS) other than hypertension (i.e., congestive heart failure, acute myocardial ischemia).
- •Patients with specific indication for treatment with β-blockers other than hypertension (i.e., heart failure, tachyarrhythmia or angina pectoris).
- •Patients with specific contra-indications for RAAS blockers (hyperkalemia, history of angioedema) and patients with a history of allergic reaction or severe hypotension after olmesartan treatment.
- •Patients with specific contra-indications for β-blockers (heart rate <60/min without a treatment with bradyarrhythmic drugs), chronic obstructive pulmonary disease or asthma and patients with history of allergic reaction after nebivolol treatment.
研究组 & 干预措施
Olmesartan
20 patients randomly allocated to single-blind antihypertensive therapy with olmesartan (20 mg/day)
干预措施: Olmesartan (Drug)
Nebivolol
20 patients randomly allocated to single-blind antihypertensive therapy with nebivolol (5 mg/day)
干预措施: Nebivolol (Drug)
No antihypertensive treatment
20 patients randomly allocated to receive no antihypertensive therapy during the acute stage of ischemic stroke
干预措施: No antihypertensive treatment (Other)
结局指标
主要结局
Between-group difference in change of 24-hour brachial BP
时间窗: Day 3 until Day 7 of stroke onset
24-hour ambulatory BP monitoring with the Mobil-O-Graph device (IEM, Germany) at baseline (Day 3 of stroke onset) and study-end (Day 7 of stroke onset)
次要结局
- Between-group difference in change of 24-hour augmentation index(Day 3 until Day 7 of stroke onset)
- Between-group difference in change of 24-hour pulse wave velocity(Day 3 until Day 7 of stroke onset)
- Between-group difference in 24-hour central aortic BP(Day 3 until Day 7 of stroke onset)
研究者
Vaios Vasileios
Principal Investigator, Division of Nephrology and Hypertension, 1st Department of Medicine, AHEPA University Hospital
Aristotle University Of Thessaloniki