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

Phase 4

• Conditions: Hypertension
• Interventions: Drug: Atorvastatin; Drug: Xuezhikang; Behavioral: Lifestyle modification

• Registration Number: NCT02254824
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-04-17
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-29
• Last Update Submitted: 2014-09-29
• Study First Posted: 2014-10-02
• Last Update Posted: 2014-10-02
• Primary Completion: 2015-10
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal-dose statin	Lifestyle modification	Lifestyle modification with Normal-dose statin
Lifestyle modification + Xuezhikang	Lifestyle modification	Lifestyle changes with Xuezhikang
Lifestyle modification	Lifestyle modification	Lifestyle modification
Normal-dose statin	Atorvastatin	Lifestyle modification with Normal-dose statin
Lifestyle modification + Xuezhikang	Xuezhikang	Lifestyle changes with Xuezhikang

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the Flow Mediated Dilatation (FMD)	1 year

Secondary Outcome Measures

Name	Time	Method
lipid profiles	1 year
the carotid - femoral Pulse Wave Velocity (cf-PWV),	1 year
inflammatory markers	1 year

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China