Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients

Chinese Academy of Medical Sciences, Fuwai Hospital

Status and phase: Unknown; Phase 4

Conditions: Hypertension

Treatments: Drug: Atorvastatin; Drug: Xuezhikang; Behavioral: Lifestyle modification

Study type: Interventional

Funder types: Other

Identifiers

NCT02254824

SF2011-4003-04

Details and patient eligibility

About

The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in hypertensive patients at low/moderate cardiovascular risk.

Full description

EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin on vascular function protection in hypertensive patients at low/moderate cardiovascular risk.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients must meet the hypertension with low or moderate cardiovascular risk following 2010 Guidelines for prevention and treatment of hypertension in China

Exclusion criteria

• Secondary Hypertension
• Women who are pregnant or lactating
• History of mental instability, or major psychiatric illness not adequately controlled and stable on therapy
• Type 2 Diabetes
• Active liver disease or impaired liver function tests
• Impaired renal function
• Uncontrolled cardiac arrhythmia
• Patient who is unable to give informed consent
• Any condition or situation, which in the opinion of the investigator, might pose a risk to the patient or confound the results of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Normal-dose statin

Active Comparator group

Description:

Lifestyle modification with Normal-dose statin

Treatment:

Behavioral: Lifestyle modification

Drug: Atorvastatin

Lifestyle modification + Xuezhikang

Active Comparator group

Description:

Lifestyle changes with Xuezhikang

Treatment:

Behavioral: Lifestyle modification

Drug: Xuezhikang

Lifestyle modification

Active Comparator group

Description:

Lifestyle modification

Treatment:

Behavioral: Lifestyle modification