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

Study Overview
=================
Brief Summary
-----------------
The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in hypertensive patients at low/moderate cardiovascular risk.

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

Official Title
-----------------
Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients (EMINENT Study)

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Xuezhikang
* Drug: Atorvastatin
* Behavioral: Lifestyle modification


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal-dose statin<br>Lifestyle modification with Normal-dose statin | Drug: Atorvastatin<br>* Atorvastatin<br>Behavioral: Lifestyle modification<br>* Lifestyle modification<br>|
| Active Comparator: Lifestyle modification + Xuezhikang<br>Lifestyle changes with Xuezhikang | Drug: Xuezhikang<br>* Xuezhikang<br>Behavioral: Lifestyle modification<br>* Lifestyle modification<br>|
| Active Comparator: Lifestyle modification<br>Lifestyle modification | Behavioral: Lifestyle modification<br>* Lifestyle modification<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the Flow Mediated Dilatation (FMD) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the carotid - femoral Pulse Wave Velocity (cf-PWV), |  | 1 year | 
| inflammatory markers |  | 1 year | 
| lipid profiles |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Xuezhikang, atorvastatin