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Different Doses of Rosuvastatin Therapy on Regression of Critical Coronary Atherosclerosis in ACS Patients

Acute Coronary Syndrome Clinical Trial

Official title:
Effect of Different Doses of Rosuvastatin Therapy on Regression of Critical Coronary Atherosclerosis in Chinese ACS Patients

Clinical Trial Summary

The purpose of this study is to determine whether Rosuvastatin 10mg/d or 20mg/d for 36 weeks can regress critical coronary atherosclerosis as determined by IVUS imaging in Chinese Acute Coronary Syndrome (ACS) patients.

Clinical Trial Description

This is a prospective, open-label, parallel group study to evaluate the efficacy of rosuvastatin 10mg/d or 20mg/d on critical coronary atherosclerosis in Chinese ACS patients. The anticipated duration of the study is approximately 36 weeks, Patients with angiographic luminal diameter narrowing in any non-culprit site between 40%-70% will be enrolled from the study site. The primary efficacy parameter is the percent change of Total Atheroma Volume (TAV) of critical coronary atherosclerosis after 36 weeks of treatment.

For inclusion in the study subjects should fulfill the following criteria:

1. Provision of informed consent prior to any study specific procedures

2. 18 to 75 years old ACS patients, male or female

3. The angiographic luminal diameter narrowing in any non-culprit site is between 40%-70%

4. statin-naive, defined as receiving no statin therapy within 3 monthsThe primary efficacy variable of the study is percent change of TAV from baseline after rosuvastatin 10mg/d or 20mg/d for 36 weeks as determined by IVUS imaging.

The secondary efficacy variables are:

- Change of blood lipid level from baseline at 12th, 24th, 36nd week

- Change of inflammatory markers from baseline at 36nd week

- Change of Percent Atheroma Volume (PAV) as determined by IVUS imaging at 36nd week ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02420899
Study type Interventional
Source Beijing Friendship Hospital
Contact Qingbo Liu, master
Phone 13552328830
Email 1035105896@qq.com
Status Recruiting
Phase N/A
Start date April 2015
Completion date July 2016
View Details
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