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 Details — Status: Recruiting

Administrative data

• NCT number: NCT02420899
• Other study ID #: 40068860-9
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2015
• Last updated: June 6, 2015
• Start date: April 2015
• Est. completion date: July 2016

Study information

• Verified date: June 2015
• Source: Beijing Friendship Hospital
• Contact: Qingbo Liu, master
• Phone: 13552328830
• Email: 1035105896[@]qq.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Atherosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Drug:
• rosuvastatin
10mg/d or 20mg/d,po

Locations

Country	Name	City	State
China	Liu Qingbo	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total Atheroma Volume (TAV)	Total Atheroma Volume	36 weeks	Yes
Other	lipid level	LDL-C,HDL-C,TC,TG	36 weeks	Yes
Other	safety and tolerability as assessed by blood biochemistry, blood routines and urine routines	blood biochemistry, blood routines and urine routines	36 weeks	Yes
Primary	Percent Atheroma Volume (PAV)	Percent Atheroma Volume	36 weeks	Yes
Secondary	inflammatory marker levels	MCP-1, VCAM-1 level and mRNA level of ICAM-1, CCR2	36 weeks	Yes