Stroke, Ischemic
Conditions
Brief summary
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
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.
Interventions
DRUGOlmesartan
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
DRUGNebivolol
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
OTHERNo antihypertensive treatment
Patients will be left without treatment
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with a first diagnosis of an acute ischemic stroke (permanent or transient) 2. BP levels \>160/100mmHg at start of the third day of hospitalization 3. BP levels \>160/100mmHg and \<220/120mmHg at start of the fourth day of hospitalization
Exclusion criteria
1. Patients with confirmed hemorrhagic stroke with computer tomography at hospital admission. 2. Patients with chronic atrial fibrillation or other cardiac arrhythmia. 3. 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}. 4. 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). 5. Patients with specific indication for treatment with β-blockers other than hypertension (i.e., heart failure, tachyarrhythmia or angina pectoris). 6. 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. 7. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between-group difference in change of 24-hour brachial BP | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Between-group difference in change of 24-hour pulse wave velocity | 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 on stroke onset) |
| Between-group difference in change of 24-hour augmentation index | 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 on stroke onset) |
| Between-group difference in 24-hour central aortic BP | 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 on stroke onset) |
Countries
Greece
Outcome results
None listed