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NCT Number: NCT03655964

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

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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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AHEPA University Hospital

Thessaloniki, 54621, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olmesartan

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

Other names: No other intervention

nebivolol

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

Other names: No other intervention

No antihypertensive treatment

Other

Patients will be left without treatment

Other names: No other intervention

Primary outcomes

  1. Between-group difference in change of 24-hour brachial BP

    Time frame: 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 outcomes

  1. Between-group difference in change of 24-hour pulse wave velocity

    Time frame: 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)

  2. Between-group difference in change of 24-hour augmentation index

    Time frame: 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)

  3. Between-group difference in 24-hour central aortic BP

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Olmesartan Versus Nebivolol in Management of Hypertension in Acute Ischemic Stroke

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 4, 2018
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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