Acute Coronary Syndrome
Conditions
Keywords
IVUS, ACS
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
Interventions
DRUGrosuvastatin
10mg/d or 20mg/d,po
Sponsors
Beijing Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Atheroma Volume (PAV) | 36 weeks | Percent Atheroma Volume |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| inflammatory marker levels | 36 weeks | MCP-1, VCAM-1 level and mRNA level of ICAM-1, CCR2 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total Atheroma Volume (TAV) | 36 weeks | Total Atheroma Volume |
| lipid level | 36 weeks | LDL-C,HDL-C,TC,TG |
| safety and tolerability as assessed by blood biochemistry, blood routines and urine routines | 36 weeks | blood biochemistry, blood routines and urine routines |
Countries
China
Contacts
Primary ContactQingbo Liu, master
Outcome results
None listed