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

January 6, 2020 updated by: Vaios Vasileios, Aristotle University Of Thessaloniki

Olmesartan Versus Nebivolol in Management of Hypertension in Acute 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54621
        • Ahepa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olmesartan
20 patients randomly allocated to single-blind antihypertensive therapy with olmesartan (20 mg/day)
Drug: 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
Other Names:
  • No other intervention
Experimental: Nebivolol
20 patients randomly allocated to single-blind antihypertensive therapy with nebivolol (5 mg/day)
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
Other Names:
  • No other intervention
Experimental: No antihypertensive treatment
20 patients randomly allocated to receive no antihypertensive therapy during the acute stage of ischemic stroke
Other: No antihypertensive treatment
Patients will be left without treatment
Other Names:
  • No other intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 3 until Day 7 of stroke onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 3 until Day 7 of stroke onset
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)
Day 3 until Day 7 of stroke onset
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)
Day 3 until Day 7 of stroke onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Eleni Georgianou, MD, School of Medicine, Aristotle University of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2018

Primary Completion (Actual)

August 20, 2019

Study Completion (Actual)

August 20, 2019

Study Registration Dates

First Submitted

August 30, 2018

First Submitted That Met QC Criteria

August 30, 2018

First Posted (Actual)

September 4, 2018

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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