Clinical trial NCT02420899: Different Doses of Rosuvastatin Therapy on Regression of Critical Coronary Atherosclerosis in ACS Patients
Official title: Effect of Different Doses of Rosuvastatin Therapy on Regression of Critical Coronary Atherosclerosis in Chinese ACS Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: IVUS
ACS
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2015-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: Percent Atheroma Volume (PAV)
timeFrame: 36 weeks
Secondary outcomes:
measure: inflammatory marker levels
timeFrame: 36 weeks
Other outcomes:
measure: Total Atheroma Volume (TAV)
timeFrame: 36 weeks
measure: lipid level
timeFrame: 36 weeks
measure: safety and tolerability as assessed by blood biochemistry, blood routines and urine routines
timeFrame: 36 weeks
Locations:
city: Beijing
country: China
facility: Liu Qingbo
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Hui Chen, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.