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

NCT03655964 | Completed Phase 2 DMC

• 1 other identifier: 3418
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Day 3 until Day 7 of stroke onset

• Between-group difference in change of 24-hour augmentation index

  Day 3 until Day 7 of stroke onset

• Between-group difference in 24-hour central aortic BP

  Day 3 until Day 7 of stroke onset

Study Arms (3)

Olmesartan

EXPERIMENTAL

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

Drug: Olmesartan

Nebivolol

EXPERIMENTAL

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

Drug: Nebivolol

No antihypertensive treatment

EXPERIMENTAL

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

Other: No antihypertensive treatment

Interventions

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

Also known as: No other intervention

Olmesartan

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

Also known as: No other intervention

Nebivolol

No antihypertensive treatment OTHER

Patients will be left without treatment

Also known as: No other intervention

No antihypertensive treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 54621, Greece

Location

Related Publications (4)

• Lobanova I, Qureshi AI. Blood Pressure Goals in Acute Stroke-How Low Do You Go? Curr Hypertens Rep. 2018 Apr 10;20(4):28. doi: 10.1007/s11906-018-0827-5.

  PMID: 29637385 BACKGROUND

• Gasecki D, Coca A, Cunha P, Hering D, Manios E, Lovic D, Zaninelli A, Sierra C, Kwarciany M, Narkiewicz K, Karaszewski B. Blood pressure in acute ischemic stroke: challenges in trial interpretation and clinical management: position of the ESH Working Group on Hypertension and the Brain. J Hypertens. 2018 Jun;36(6):1212-1221. doi: 10.1097/HJH.0000000000001704.

  PMID: 29621070 BACKGROUND

• Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31.

  PMID: 23370205 BACKGROUND

• Georgianou E, Georgianos PI, Petidis K, Markakis K, Zografou I, Karagiannis A. Effect of Nebivolol and Olmesartan on 24-Hour Brachial and Aortic Blood Pressure in the Acute Stage of Ischemic Stroke. Int J Hypertens. 2019 Oct 7;2019:9830295. doi: 10.1155/2019/9830295. eCollection 2019.

  PMID: 31687205 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

olmesartan; Nebivolol

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Eleni Georgianou, MD

  School of Medicine, Aristotle University of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Division of Nephrology and Hypertension, 1st Department of Medicine, AHEPA University Hospital

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 4, 2018
• Study Start: August 20, 2018
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)