Rosuvastatin Effect on Reducing Coronary Atherosclerosis Plaques Volume

Coronary Artery Disease Clinical Trial

— REDUCT  

Official title:

Rosuvastatin Effect on Reducing Coronary Atherosclerosis Plaques Volume Evaluated by Multi-slice Spiral CT in Patients With Stable Coronary Heart Disease and Hyperlipidemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01382277
• Other study ID #: REDUCT
• Status: Recruiting
• Phase: Phase 4
• First received: June 20, 2011
• Last updated: June 23, 2011
• Start date: March 2011
• Est. completion date: April 2013

Study information

• Verified date: February 2011
• Source: Peking University First Hospital
• Contact: Jie Jiang, MD
• Phone: 86-10-66551383
• Email: jiangjie[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This multicentre, open-label, single-arm Study is to evaluate the effect of Rosuvastatin 20 mg 76 weeks on coronary atherosclerosis plaque versus baseline in Chinese coronary heart disease (CHD) patients with hyperlipidemia by measuring the plaque volume using a 64 slice spiral CT. Effect on blood lipids, hsCRP and Carotid intima-media thickness (CIMT) is also evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Hyperlipidemia
• Hyperlipidemias
• Myocardial Ischemia

Intervention

Drug:
• Rosuvastatin
Rosuvastatin 20 mg per day for 76 weeks

Locations

Country	Name	City	State
China	Division of Cardiology, Peking University First Hospital	Beijing
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in coronary atherosclerosis plaque volume using a 64 slice spiral CT at 76 weeks		76 weeks	No
Secondary	Change from baseline in blood lipids at 26 weeks		26 weeks	No
Secondary	Change from baseline in hsCRP at 26 weeks		26 weeks	No
Secondary	Change from baseline in Carotid intima-media thickness at 76 weeks		76 weeks	No
Secondary	Number of participants with adverse events and abnormal laboratory safety markers.		76 weeks	Yes
Secondary	Change from baseline in blood lipids at 52 weeks		52 weeks	No
Secondary	Change from baseline in blood lipids at 76 weeks		76 weeks	No
Secondary	Change from baseline in hsCRP at 52 weeks		52 weeks	No
Secondary	Change from baseline in hsCRP at 76 weeks		76 weeks	No