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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Provision of informed consent prior to any study specific procedures 18 to 75 years old ACS patients, male or female The angiographic luminal diameter narrowing in any non-culprit site is between 40%-70% 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

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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion 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 months; Exclusion Criteria: Have received statin therapy within 3 months; The angiographic luminal diameter narrowing in any coronary vessels is more than 70%; Active liver disease, ALT≥3*ULN; Renal function damage, CrCl<30ml/min; Myopathy; Pregnancy, lactation female; Using cyclosporine; Patients with uncontrolled triglyceride levels TG≥5.65 mmol／L; Poorly controlled diabetes (HbA1c≥10%）Hypersensitivity to rosuvastatin or any of the recipients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Statins,lipid-lowering drugs<br>rosuvastatin 10mg or 20mg per day，pro | Drug: rosuvastatin<br>* 10mg/d or 20mg/d,po<br>* Other names: crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Atheroma Volume (PAV) | Percent Atheroma Volume | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory marker levels | MCP-1, VCAM-1 level and mRNA level of ICAM-1, CCR2 | 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVUS, ACS