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

Stroke, Ischemic Clinical Trial

Official title:

Olmesartan Versus Nebivolol in Management of Hypertension in Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03655964
• Other study ID #: 3418
• Status: Completed
• Phase: Phase 2
• Start date: August 20, 2018
• Est. completion date: August 20, 2019

Study information

• Verified date: January 2020
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 20, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 ß-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 ß-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.

Related Conditions & MeSH terms

• Ischemia
• Stroke
• Stroke, Ischemic

Intervention

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
• 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:
• No antihypertensive treatment
Patients will be left without treatment

Locations

Country	Name	City	State
Greece	AHEPA University Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Day 3 until Day 7 of stroke onset
Secondary	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)	Day 3 until Day 7 of stroke onset
Secondary	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)	Day 3 until Day 7 of stroke onset