Rosuvastatin Effect on Reducing Coronary Atherosclerosis Plaques Volume (REDUCT)

This is an interventional treatment trial for Hyperlipidemia Read More

Inclusion Criteria:

• Written informed consent
• Men or women, aged 18 -75

• Diagnosed with coronary heart disease (CHD) stable angina for more than 1 month and meet the following any one:

  1. History of myocardial infarction.
  2. CHD confirmed by coronary angiography.
  3. Excercise ECG positive for CHD or perfusion defect
  4. One or more main branch of coronary artery stenosis ≥ 50% confirmed by CT scanning.
• Hyperlipidemia (lipid-lowering treatment naïve: LDL-C ≥130mg/dl, or having received lipid-lowering treatment: LDL-C ≥100mg/dl)

• The 64 slice CT shows at least one significant coronary artery stenosis ≥20% with the narrowest ≤60% and meeting the following criteria:

  1. Diameter of coronary artery lesion ≥2mm, length ≥5mm; distance between multiple lesions >1cm
  2. Plaque density <100HU, no calcification
  3. Vascular stenosis (20～60%) caused by plaques
  4. Plaque thickness >1mm
  5. Plaque not in the coronary artery with previous PCI treatment.

Exclusion Criteria:

• Acute myocardial infarction within 6 months
• PCI or CABG therapy within 6 months
• Anticipated PCI or CABG therapy in the following 3 months.
• Tropnin I/Tropnin T higher than ULN
• Cardiac failure NYHA III or above
• Coronary artery left main stenosis >50%
• Emergency coronary angiography(CAG) is needed
• Serious arrhythmia or tachycardia
• Secondary hyperlipidemia
• Familial hypercholestrolemia
• Uncontrolled severe hypertension (≥200/110 mmHg)
• Uncontrolled diabetes (HbA1c ≥9.5%)
• Triglyceride ≥500 mg/dL (5.65 mmol/L)
• Active hepatic disease or hepatic function impairment, ALT≥3ULN
• Serum creatinine >177 µmol/L (2.0 mg/dL)
• Myalgia or blood CK ≥5ULN
• WBC < 4×10e9/L，or PLT < 100*10e9/L。
• Participation in the the course of plan and/or procedure of this study
• Previous participation in the study treatment
• Participation in other clinical studies in the past 3 months
• Pregnant or breast-feeding women, women with child-bearing potential who did not use drugs or devices for contraception, or women with positive urine pregnancy test (human chorionic gonadotropin [HCG])
• History of malignant tumors (exception: recovered more than 10 years or only basal cell carcinoma or squamous cell carcinoma); females with a history of cervical atypical hyperplasia (exception: 3 consecutive cervical smear tests normal prior to enrolment)
• History of alcohol and/or drug abuse in recent 5 years
• Any serious or unstable physical or psychological conditions, in the opinion of the investigator, would compromise the safety of the patient or the participation in this study
• Use of concomitant medications prohibited in this study ( Erythromycin, clarithromycin, erythromycin ethylsuccinate, sulfaphenazole; Fluconazole, ketoconazole, itraconazole; Niacin / nicotinic acid(including vitamins/food additives containing niacin / nicotinic acid >50mg), probucol, clofibrate, cholestyramine, colestipol hydrochloride, ezetimibe, fenofibrate, gemfibrozil, atorvastatin(exception: study medication)，lovastatin, pravastatin, rosuvastatin (exception: study medication) , Simvastatin, fluvastatin, fish oil (any dose), lipid-lowering supplements and food additives; Cyclosporine; Protease inhibitors)
• Use of periodic hormone replacement treatment(HRT), oral contraceptives(OCTs), long-acting progesterone, or in recent 3 months non-periodic HRT or OCTs
• Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding