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

Not Applicable

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: rosuvastatin

• Registration Number: NCT02420899
• Lead Sponsor: Beijing Friendship Hospital

Brief 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.

Detailed 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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-17
• Study First Posted: 2015-04-20
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-06
• Last Update Posted: 2015-06-09
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Statins,lipid-lowering drugs	rosuvastatin	rosuvastatin 10mg or 20mg per day，pro

Primary Outcome Measures

Name	Time	Method
Percent Atheroma Volume (PAV)	36 weeks	Percent Atheroma Volume

Secondary Outcome Measures

Name	Time	Method
inflammatory marker levels	36 weeks	MCP-1, VCAM-1 level and mRNA level of ICAM-1, CCR2

Trial Locations

Locations (1)

Liu Qingbo; 🇨🇳 Beijing, Beijing, China