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

Primary Purpose

Stroke, Ischemic

Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Olmesartan
Nebivolol
No antihypertensive treatment
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AHEPA University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Olmesartan

Nebivolol

No antihypertensive treatment

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)

Full Information

First Posted
August 30, 2018
Last Updated
January 6, 2020
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT03655964
Brief Title
Effect of Olmesartan and Nebivolol on Ambulatory Blood Pressure and Arterial Stiffness in Acute Stage of Ischemic Stroke
Official Title
Olmesartan Versus Nebivolol in Management of Hypertension in Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
August 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olmesartan
Arm Type
Experimental
Arm Description
20 patients randomly allocated to single-blind antihypertensive therapy with olmesartan (20 mg/day)
Arm Title
Nebivolol
Arm Type
Experimental
Arm Description
20 patients randomly allocated to single-blind antihypertensive therapy with nebivolol (5 mg/day)
Arm Title
No antihypertensive treatment
Arm Type
Experimental
Arm Description
20 patients randomly allocated to receive no antihypertensive therapy during the acute stage of ischemic stroke
Intervention Type
Drug
Intervention Name(s)
Olmesartan
Other Intervention Name(s)
No other intervention
Intervention Description
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
Intervention Name(s)
Nebivolol
Other Intervention Name(s)
No other intervention
Intervention Description
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
Other
Intervention Name(s)
No antihypertensive treatment
Other Intervention Name(s)
No other intervention
Intervention Description
Patients will be left without treatment
Primary Outcome Measure Information:
Title
Between-group difference in change of 24-hour brachial BP
Description
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 Outcome Measure Information:
Title
Between-group difference in change of 24-hour pulse wave velocity
Description
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
Title
Between-group difference in change of 24-hour augmentation index
Description
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
Title
Between-group difference in 24-hour central aortic BP
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleni Georgianou, MD
Organizational Affiliation
School of Medicine, Aristotle University of Thessaloniki
Official's Role
Principal Investigator
Facility Information:
Facility Name
AHEPA University Hospital
City
Thessaloniki
ZIP/Postal Code
54621
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29637385
Citation
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.
Results Reference
background
PubMed Identifier
29621070
Citation
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.
Results Reference
background
PubMed Identifier
23370205
Citation
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.
Results Reference
background
PubMed Identifier
31687205
Citation
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.
Results Reference
derived

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

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