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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-06-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Coronary Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Olmesartan medoxomil tablets

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Antihypertensive medication (per doctor suggestion)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Benicar no other names

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No