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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-20

Study Completion Date

2019-08-20

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

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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.

Conditions

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Stroke, Ischemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Olmesartan

20 patients randomly allocated to single-blind antihypertensive therapy with olmesartan (20 mg/day)

Group Type EXPERIMENTAL

Olmesartan

Intervention Type DRUG

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

Nebivolol

20 patients randomly allocated to single-blind antihypertensive therapy with nebivolol (5 mg/day)

Group Type EXPERIMENTAL

Nebivolol

Intervention Type DRUG

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

No antihypertensive treatment

20 patients randomly allocated to receive no antihypertensive therapy during the acute stage of ischemic stroke

Group Type EXPERIMENTAL

No antihypertensive treatment

Intervention Type OTHER

Patients will be left without treatment

Interventions

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Olmesartan

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

Intervention Type DRUG

Nebivolol

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

Intervention Type DRUG

No antihypertensive treatment

Patients will be left without treatment

Intervention Type OTHER

Other Intervention Names

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No other intervention No other intervention No other intervention

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No