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

NCT ID: NCT02420899

Last Updated: 2015-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-07-31

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

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Statins,lipid-lowering drugs

rosuvastatin 10mg or 20mg per day，pro

Group Type: EXPERIMENTAL

rosuvastatin

Intervention Type: DRUG

10mg/d or 20mg/d,po

Interventions

rosuvastatin

10mg/d or 20mg/d,po

Intervention Type: DRUG

Other Intervention Names

crestor

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hui Chen

Hui Chen,Director,Clinical Professor,Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui Chen, doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

Liu Qingbo

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qingbo Liu, master

Role: CONTACT

1035105896@qq.com

13552328830

Facility Contacts

Qingbo Liu, master

Role: primary

1035105896@qq.com

13552328830

References

1.Liao J K, Laufs U. Pleiotropic effects of statins[J]. Annual review of pharmacology and toxicology, 2005, 45: 89. 2.Davignon J. Beneficial cardiovascular pleiotropic effects of statins[J]. Circulation, 2004, 109(23 suppl 1): III-39-III-43. 3.Falk E, Shah P K, Fuster V. Coronary plaque disruption[J]. Circulation, 1995, 92(3): 657-671. 4. Nissen SE, Nicholls SJ, Sipahi I, et al.Effect of very high-intensity statin therapy on regression of coronary atherosclerosis:the ASTEROID trial. JAMA, 2006; 295: 1556-65. 5. Lee CW, et al. Comparison of Effects of Atorvastatin(20mg) Versus Rosuvastatin(10mg) Therapy on Mild Coronary Atherosclerosis Plaques(from the ARTMAP Trial).Am J Cardiol, 2012; 109:1700-1704.

Reference Type: BACKGROUND

Other Identifiers

40068860-9

Identifier Type: -

Identifier Source: org_study_id