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

Phase 2

Completed

• Conditions: Stroke, Ischemic
• Interventions: Other: No antihypertensive treatment; Drug: Olmesartan; Drug: Nebivolol

• Registration Number: NCT03655964
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Study Timeline

• Study Start: 2018-08-20
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-08-30
• Study First Posted: 2018-09-04
• Primary Completion: 2019-08-20
• Study Completion: 2019-08-20
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No antihypertensive treatment	No antihypertensive treatment	20 patients randomly allocated to receive no antihypertensive therapy during the acute stage of ischemic stroke
Olmesartan	Olmesartan	20 patients randomly allocated to single-blind antihypertensive therapy with olmesartan (20 mg/day)
Nebivolol	Nebivolol	20 patients randomly allocated to single-blind antihypertensive therapy with nebivolol (5 mg/day)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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)

Trial Locations

Locations (1)

AHEPA University Hospital; 🇬🇷 Thessaloniki, Greece