Effect of Olmesartan and Nebivolol on Ambulatory Blood Pressure and Arterial Stiffness in Acute Stage of Ischemic Stroke

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Olmesartan Versus Nebivolol in Management of Hypertension in Acute Ischemic Stroke

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Drug: Olmesartan
* Drug: Nebivolol
* Other: No antihypertensive treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olmesartan<br>20 patients randomly allocated to single-blind antihypertensive therapy with olmesartan (20 mg/day) | Drug: Olmesartan<br>* At Day 4 of stroke onset, patients with clinic BP >160/100 mmHg will receive olmesartan 20 mg once daily until Day 7 of stroke onset<br>* Other names: No other intervention;|
| Experimental: Nebivolol<br>20 patients randomly allocated to single-blind antihypertensive therapy with nebivolol (5 mg/day) | Drug: Nebivolol<br>* At Day 4 of stroke onset, patients with clinic BP >160/100 mmHg will receive nebivolol 5mg once daily until Day 7 of stroke onset<br>* Other names: No other intervention;|
| Experimental: No antihypertensive treatment<br>20 patients randomly allocated to receive no antihypertensive therapy during the acute stage of ischemic stroke | Other: No antihypertensive treatment<br>* Patients will be left without treatment<br>* Other names: No other intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-group difference in change of 24-hour brachial BP | 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) | Day 3 until Day 7 of stroke onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-group difference in change of 24-hour pulse wave velocity | 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 on stroke onset) | Day 3 until Day 7 of stroke onset | 
| Between-group difference in change of 24-hour augmentation index | 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 on stroke onset) | Day 3 until Day 7 of stroke onset | 
| Between-group difference in 24-hour central aortic BP | 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 on stroke onset) | Day 3 until Day 7 of stroke onset |