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

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ClinicalTrials.gov Identifier: NCT02360956
Recruitment Status : Unknown
Verified February 2015 by Yundai Chen, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : February 11, 2015
Last Update Posted : February 11, 2015
Sponsor:
Information provided by (Responsible Party):
Yundai Chen, Chinese PLA General Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
Coronary Atherosclerosis Drug: Olmesartan medoxomil tablets Drug: Antihypertensive medication (per doctor suggestion) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : December 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Olmesartan medoxomil
Drug: 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.
Drug: Olmesartan medoxomil tablets
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.
Other Name: Benicar

Active Comparator: Antihypertensive medication

Drug: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.

Drug: Antihypertensive medication (per doctor suggestion)
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.
Other Name: no other names




Primary Outcome Measures :
  1. Coronary atherosclerosis progression detected by CCTA [ Time Frame: 12 month ]
    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

  2. Epicardial Adipose Tissue(EAT) volume detected by CCTA [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. The relationship between coronary atherosclerosis and EAT, as indicated by coronary atherosclerosis progression and epicardial adipose tissue(EAT) volume changes [ Time Frame: 12 month ]
  2. Serum levels of blood lipids [ Time Frame: 12 month ]
    Blood lipids include total cholesterol,triglyceride,high density lipoprotein(HDL) and low density lipoprotein(LDL).

  3. Serum levels of blood glucose [ Time Frame: 12 month ]
    Blood glucose is defined as fasting blood glucose(FBG).

  4. Circulating surrogate markers of atherosclerosis inflammation including hs-CRP,IL-6,MCP-1,TNF--α and MMP-9 [ Time Frame: 12 month ]
    CRP: C reactive protein; IL: Interleukin; MCP: Monocyte chemotactic protein,composite of chemoattractant markers; TNF-α: tumor necrosis factor; MMP: Matrix metalloproteinase.

  5. Individual circulating surrogate markers of endothelial function including NO and ET-1 [ Time Frame: 12 month ]
    ET: Endothelin

  6. Individual circulating surrogate markers of adipose tissue inflammation and metabolism including adiponectin and leptin. [ Time Frame: 12 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT02360956


Contacts
Contact: Zhou Ying 86-15810836908 zhouying0129@126.com

Locations
China
Chinese PLA General Hospital Recruiting
Beijing, China, 100853
Contact: Chen Yundai    86-10-55499246    cyundai301@126.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Principal Investigator: Chen Yundai Chinese PLA General Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yundai Chen, Director of Cardiology,People's Liberation Army General Hospital, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02360956     History of Changes
Other Study ID Numbers: S2014-119-01
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: February 2015

Keywords provided by Yundai Chen, Chinese PLA General Hospital:
Olmesartan medoxomil
Epicardial adipose tissue
Multidetector Computed Tomography

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Olmesartan
Antihypertensive Agents
Olmesartan Medoxomil
Calcium Channel Blockers
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Membrane Transport Modulators