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Coronary AtherosclerosisPhase 4NCT02360956

Efficacy Study of Olmesartan Medoxomil on Coronary Atherosclerosis and Epicardial Adipose Tissue(EAT)

A Phase 4 study testing Olmesartan medoxomil tablets and Antihypertensive medication (per doctor suggestion) in people with Coronary Atherosclerosis, run by Chinese PLA General Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether olmesartan medoxomil is effective in the treatment of coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume reduction in patients with coronary atherosclerosis detected by coronary CT angiography(CCTA). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Atherosclerosis
What is being tested?
Olmesartan medoxomil tablets and Antihypertensive medication (per doctor suggestion)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
Dec 2014to Jun 2016
Phase
Phase 4
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • coronary artery stenosis between 30% and 70% determined by CCTA in essential hypertension patients
  • resting diastolic blood pressure (DBP) between 90 and 110 mmHg
  • type A and B for coronary artery vascular lesions

Who cannot join

  • secondary hypertension
  • coronary artery stenosis less than 30% or greater than 70% determined by CCTA
  • contraindications to treatment with olmesartan medoxomil (allergy, glaucoma, digestive ulcer, is currently taking phosphodiesterase-5 inhibitor)
  • resting systolic blood pressure (SBP) > 200 mmHg or resting diastolic blood pressure (DBP) > 110 mmHg
  • Severe calcification, distortion or type C for coronary artery vascular lesions
  • pregnancy
  • unwillingness or inability to provide informed consent

Trial locations and contacts

1 site in 1 country.

Zhou Ying contact

86-15810836908

zhouying0129@126.com

China1 site, 1 recruiting

  • Chinese PLA General Hospital

    Beijing, 100853

    Chen Yundai, 86-10-55499246, cyundai301@126.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy Study of Olmesartan Medoxomil on Coronary Atherosclerosis Progression and Epicardial Adipose Tissue(EAT) Volume Reduction in Patients With Coronary Atherosclerosis Detected by Coronary CT Angiography(CCTA)

The purpose of this study is to determine whether olmesartan medoxomil is effective in the treatment of coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume reduction in patients with coronary atherosclerosis detected by coronary CT angiography(CCTA).

Read the detailed description

Epicardial adipose tissue(EAT) is directly deposited around the pericardium and coronary artery. By means of paracrine action, it can generate various kinds of cytokines, inflammatory factor and free fatty acids, that can affect the state of coronary endothelial function, inflammation and oxidative stress, which finally aggravate the progression of coronary atherosclerosis. In recent years, clinical studies have shown that EAT is a newly discovered independent risk factor of coronary atherosclerosis.Studies confirm that olmesartan medoxomil can improve endothelial function, resisting thrombosis, improve tissue reconstruction, resisting oxidative stress so as to achieve atherosclerosis resistant. Latest researches show that olmesartan medoxomil can better inhibit rat epididymal adipose cell hypertrophy and inflammatory reaction. Coronary CT angiography(CCTA) has emerged as a noninvasive imaging method for analysis coronary atherosclerosis. The purpose of this study is to determine whether olmesartan medoxomil is effective in the treatment of coronary atherosclerosis progression and EAT volume reduction in patients with coronary atherosclerosis detected by CCTA.

Being tested
Olmesartan medoxomil tablets, Antihypertensive medication (per doctor suggestion)
Keywords
Olmesartan medoxomil, Epicardial adipose tissue, Multidetector Computed Tomography
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Olmesartan medoxomil tabletsDrug

    Also called Benicar

    Dosage must be individualized. The usual recommended starting dose of Benicar is 20mg once daily when used as monotherapy in patients who are not volume-contracted.For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Benicar may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.

  • Antihypertensive medication (per doctor suggestion)Drug

    Also called no other names

    Any antihypertensive medication alone or in combination.Calcium channel blockers (CCBs),diuretics, beta-blockers, or other antihypertensive medication except ACE inhibitors or ARBs.The drug dose must be individualed.Dosage must be individualized.The patients should take the antihypertensive drugs according to doctors'suggestion.

Study groups in NCT02360956
Study groupRoleWhat they receive
Olmesartan medoxomilExperimentalDrug: Olmesartan medoxomil tablets(Daiichi Sankyo Inc, Japan). The initial dose is 20mg once daily. If blood pressure requiring further reduction after two weeks, olmesartan medoxomil may be increased to 40mg once daily.
Receives: Drug: Olmesartan medoxomil tablets
Antihypertensive medicationActive comparatorDrug:Any antihypertensive medication alone or in combination.Calcium channel blockers (CCBs),diuretics, beta-blockers, or other antihypertensive medication except angiotensin-Converting Enzyme Inhibitors inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs). The drug dose must be individualized.
Receives: Drug: Antihypertensive medication (per doctor suggestion)

What is being measured

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

  1. Coronary atherosclerosis progression detected by CCTA

    Coronary atherosclerosis progression is defined as ≥10% diameter reduction or progression of a pre-existing coronary stenosis; or ≥0.2mm reduction or progression of the minimal luminal area (MLD) in the lesion

    Measured: 12 month

  2. Epicardial Adipose Tissue(EAT) volume detected by CCTA

    Measured: 12 month

Secondary outcomes (6)

  1. The relationship between coronary atherosclerosis and EAT, as indicated by coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume changes

    Measured: 12 month

  2. Serum levels of blood lipids

    Blood lipids include total cholesterol,triglyceride,high density lipoprotein(HDL) and low density lipoprotein(LDL).

    Measured: 12 month

  3. Serum levels of blood glucose

    Blood glucose is defined as fasting blood glucose(FBG).

    Measured: 12 month

  4. Circulating surrogate markers of atherosclerosis inflammation including hs-CRP,IL-6,MCP-1,TNF--α and MMP-9

    CRP: C reactive protein; IL: Interleukin; MCP: Monocyte chemotactic protein,composite of chemoattractant markers; TNF-α: tumor necrosis factor; MMP: Matrix metalloproteinase.

    Measured: 12 month

  5. Individual circulating surrogate markers of endothelial function including NO and ET-1

    ET: Endothelin

    Measured: 12 month

  6. Individual circulating surrogate markers of adipose tissue inflammation and metabolism including adiponectin and leptin.

    Measured: 12 month

Timeline

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

  1. First posted11 Feb 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionJun 2016 (estimated)
  4. Study completionJun 2016 (estimated)

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02360956
Sponsor's protocol ID
S2014-119-01
Status last verified
Feb 2015
First submitted
15 Jan 2015
Last updated
11 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • Alexopoulos N, McLean DS, Janik M, Arepalli CD, Stillman AE, Raggi P. Epicardial adipose tissue and coronary artery plaque characteristics. Atherosclerosis. 2010 May;210(1):150-4. doi: 10.1016/j.atherosclerosis.2009.11.020. Epub 2009 Nov 20.

    PubMed 20031133

  • Cherian S, Lopaschuk GD, Carvalho E. Cellular cross-talk between epicardial adipose tissue and myocardium in relation to the pathogenesis of cardiovascular disease. Am J Physiol Endocrinol Metab. 2012 Oct 15;303(8):E937-49. doi: 10.1152/ajpendo.00061.2012. Epub 2012 Aug 14.

    PubMed 22895783

  • Ferrario C. Effect of angiotensin receptor blockade on endothelial function: focus on olmesartan medoxomil. Vasc Health Risk Manag. 2009;5(1):301-14. doi: 10.2147/vhrm.s3141. Epub 2009 Apr 8.

    PubMed 19436655

  • Maeda A, Tamura K, Wakui H, Ohsawa M, Azushima K, Uneda K, Kanaoka T, Kobayashi R, Ohki K, Matsuda M, Tsurumi-Ikeya Y, Yamashita A, Tokita Y, Umemura S. Effects of the Angiotensin receptor blocker olmesartan on adipocyte hypertrophy and function in mice with metabolic disorders. Biomed Res Int. 2014;2014:946492. doi: 10.1155/2014/946492. Epub 2014 Jun 2.

    PubMed 24991574

  • Zhou Y, Tian F, Wang J, Yang JJ, Zhang T, Jing J, Chen YD. Efficacy study of olmesartan medoxomil on coronary atherosclerosis progression and epicardial adipose tissue volume reduction in patients with coronary atherosclerosis detected by coronary computed tomography angiography: study protocol for a randomized controlled trial. Trials. 2016 Jan 6;17:10. doi: 10.1186/s13063-015-1097-z.

    PubMed 26739013

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Olmesartan medoxomil tablets and Antihypertensive medication (per doctor suggestion) in people with Coronary Atherosclerosis, run by Chinese PLA General Hospital at 1 site in China.

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: status not confirmed, as of the sponsor's last update on 11 Feb 2015. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Zhou Ying (86-15810836908, zhouying0129@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coronary atherosclerosis progression detected by CCTA (time frame: 12 month). The study lists 2 primary outcomes in all. 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 NCT02360956, which also lists 5 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 11 Feb 2015.

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