AzTrials
AzTrials

Stroke, IschemicPhase 2NCT03655964

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

A Phase 2 study testing Olmesartan, Nebivolol and No antihypertensive treatment in people with Stroke, Ischemic, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke, Ischemic
What is being tested?
Olmesartan, Nebivolol and No antihypertensive treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteGreece
Study dates
20 Aug 2018to 20 Aug 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • AHEPA University Hospital

    Thessaloniki, 54621

Other trials in Greece

About this study

Official title: 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

Read the 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.

Being tested
Olmesartan, Nebivolol, No antihypertensive treatment
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlmesartanDrug

    Also called No other intervention

    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

  • NebivololDrug

    Also called No other intervention

    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 treatmentOther

    Also called No other intervention

    Patients will be left without treatment

Study groups in NCT03655964
Study groupRoleWhat they receive
OlmesartanExperimental20 patients randomly allocated to single-blind antihypertensive therapy with olmesartan (20 mg/day)
Receives: Drug: Olmesartan
NebivololExperimental20 patients randomly allocated to single-blind antihypertensive therapy with nebivolol (5 mg/day)
Receives: Drug: Nebivolol
No antihypertensive treatmentExperimental20 patients randomly allocated to receive no antihypertensive therapy during the acute stage of ischemic stroke
Receives: Other: No antihypertensive treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Day 3 until Day 7 of stroke onset

Secondary outcomes (3)

  1. 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)

    Measured: Day 3 until Day 7 of stroke onset

  2. 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)

    Measured: Day 3 until Day 7 of stroke onset

  3. 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)

    Measured: Day 3 until Day 7 of stroke onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2018
  2. Study start20 Aug 2018
  3. Primary completion20 Aug 2019
  4. Study completion20 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03655964
Sponsor's protocol ID
3418
Status last verified
Jan 2020
First submitted
30 Aug 2018
Last updated
7 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29637385

  • 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.

    PubMed 29621070

  • 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.

    PubMed 23370205

  • 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.

    PubMed 31687205

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olmesartan, Nebivolol and No antihypertensive treatment in people with Stroke, Ischemic, run by Aristotle University Of Thessaloniki at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Between-group difference in change of 24-hour brachial BP (time frame: Day 3 until Day 7 of stroke onset). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03655964, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in