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CompletedNCT03655964Updated Jan 7, 2020

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

A Phase 2 interventional study of Olmesartan and Nebivolol in Stroke, Ischemic, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-01-07.

Sponsored by Aristotle University Of Thessaloniki · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Stroke, Ischemic

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03

In context

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

This study's enrollment of 60 is below the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Browse Aristotle University Of Thessaloniki studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Olmesartan

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

    Drug: Olmesartan

  • Experimental
    Nebivolol

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

    Drug: Nebivolol

  • Experimental
    No antihypertensive treatment

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

    Other: No antihypertensive treatment

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

    Also known as: No other intervention

  • 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

    Also known as: No other intervention

  • OtherNo antihypertensive treatment

    Patients will be left without treatment

    Also known as: No other intervention

06

What researchers measure

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)

    Time frame: Day 3 until Day 7 of stroke onset

Secondary outcomes

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

    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)

    Time frame: Day 3 until Day 7 of stroke onset

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

    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)

    Time frame: Day 3 until Day 7 of stroke onset

  3. Between-group difference in 24-hour central aortic 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 on stroke onset)

    Time frame: Day 3 until Day 7 of stroke onset

07

Study locations

1 site
  • AHEPA University Hospital
    Thessaloniki, 54621, Greece
08

References and documents

Publications

  • 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. PubMed 29637385 ↗
  • 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. PubMed 29621070 ↗
  • 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. PubMed 23370205 ↗
  • 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. PubMed 31687205 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2018 to primary completion in Aug 2019, 12 months.

Of 85 non-industry phase 2 interventional studies under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's 12 months is below that.

Counting every sponsor, half of 127 studies reached it within 28 months; a quarter within 15 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2018
First posted
Sep 4, 2018
StartActual
Aug 20, 2018
Primary completionActual
Aug 20, 2019
CompletionActual
Aug 20, 2019
Last update
Jan 7, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03655964
Lead sponsor
Aristotle University Of Thessaloniki
Responsible party
Vaios Vasileios (Principal Investigator, Division of Nephrology and Hypertension, 1st Department of Medicine, AHEPA University Hospital, Aristotle University Of Thessaloniki) — Principal investigator
First posted
Sep 4, 2018
Start date
Aug 20, 2018
Primary completion
Aug 20, 2019
Completion
Aug 20, 2019
Last update
Jan 7, 2020

Study contacts

Eleni Georgianou, MD
principal investigator · School of Medicine, Aristotle University of Thessaloniki

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Olmesartan · Nebivolol

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