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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 4

Conditions: Coronary Atherosclerosis

Treatments: Drug: Antihypertensive medication (per doctor suggestion); Drug: Olmesartan medoxomil tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT02360956

S2014-119-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Olmesartan medoxomil

Experimental group

Description:

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.

Treatment:

Drug: Olmesartan medoxomil tablets

Antihypertensive medication

Active Comparator group

Description:

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.

Treatment:

Drug: Antihypertensive medication (per doctor suggestion)