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Trial record 24 of 134 for:    OLMESARTAN

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

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ClinicalTrials.gov Identifier: NCT03655964
Recruitment Status : Recruiting
First Posted : September 3, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Vaios Vasileios, Aristotle University Of Thessaloniki

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

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Drug: Olmesartan Drug: Nebivolol Other: No antihypertensive treatment Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Olmesartan Versus Nebivolol in Management of Hypertension in Acute Ischemic Stroke
Actual Study Start Date : August 20, 2018
Estimated Primary Completion Date : August 20, 2019
Estimated Study Completion Date : August 20, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: No other intervention




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655964


Contacts
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Contact: Eleni I. Georgianou, MD 00306974939225 elenigeorgi@hotmail.com
Contact: Asterios Karagiannis, MD, PhD 00302310992845 astkar@med.auth.gr

Locations
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Greece
AHEPA University Hospital Recruiting
Thessaloniki, Greece, 54621
Contact: Vasileios Vaios, MD         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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Principal Investigator: Eleni Georgianou, MD School of Medicine, Aristotle University of Thessaloniki

Publications:
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Responsible Party: Vaios Vasileios, Principal Investigator, Division of Nephrology and Hypertension, 1st Department of Medicine, AHEPA University Hospital, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT03655964     History of Changes
Other Study ID Numbers: 3418
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Olmesartan
Olmesartan Medoxomil
Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Nebivolol
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs