Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olmesartan | Experimental | 20 patients randomly allocated to single-blind antihypertensive therapy with olmesartan (20 mg/day) |
|
| Nebivolol | Experimental | 20 patients randomly allocated to single-blind antihypertensive therapy with nebivolol (5 mg/day) |
|
| No antihypertensive treatment | Experimental | 20 patients randomly allocated to receive no antihypertensive therapy during the acute stage of ischemic stroke |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olmesartan | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Between-group difference in change of 24-hour augmentation index |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eleni Georgianou, MD | School of Medicine, Aristotle University of Thessaloniki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AHEPA University Hospital | Thessaloniki | 54621 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29637385 | Background | 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. | |
| 29621070 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C437965 | olmesartan |
| D000068577 | Nebivolol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nebivolol | Drug | 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 |
|
|
| No antihypertensive treatment | Other | Patients will be left without treatment |
|
|
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 | 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 |
| 23370205 | Background | 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. |
| 31687205 | Derived | 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. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000588 |
| Amines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |