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Rosuvastatin Effect on Reducing Coronary Atherosclerosis Plaques Volume (REDUCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01382277
Recruitment Status : Unknown
Verified February 2011 by Peking University First Hospital.
Recruitment status was:  Recruiting
First Posted : June 27, 2011
Last Update Posted : June 27, 2011
Information provided by:
Peking University First Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Coronary Artery Disease Drug: Rosuvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2011
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Rosuvastatin 20 mg
Rosuvastatin 20 mg for 76 weeks.
Drug: Rosuvastatin
Rosuvastatin 20 mg per day for 76 weeks
Other Name: Crestor

Primary Outcome Measures :
  1. Change from baseline in coronary atherosclerosis plaque volume using a 64 slice spiral CT at 76 weeks [ Time Frame: 76 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in blood lipids at 26 weeks [ Time Frame: 26 weeks ]
  2. Change from baseline in hsCRP at 26 weeks [ Time Frame: 26 weeks ]
  3. Change from baseline in Carotid intima-media thickness at 76 weeks [ Time Frame: 76 weeks ]
  4. Number of participants with adverse events and abnormal laboratory safety markers. [ Time Frame: 76 weeks ]
  5. Change from baseline in blood lipids at 52 weeks [ Time Frame: 52 weeks ]
  6. Change from baseline in blood lipids at 76 weeks [ Time Frame: 76 weeks ]
  7. Change from baseline in hsCRP at 52 weeks [ Time Frame: 52 weeks ]
  8. Change from baseline in hsCRP at 76 weeks [ Time Frame: 76 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01382277

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Contact: Jie Jiang, MD 86-10-66551383

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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Yanjun Gong, MD    86-10-83572299   
Division of Cardiology, Peking University First Hospital Recruiting
Beijing, China, 100034
Contact: Jie Jiang, MD    86-10-66551383      
Sponsors and Collaborators
Peking University First Hospital
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Principal Investigator: Yong Huo, MD Peking University First Hospital

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Responsible Party: Yong Huo, Peking University First Hospital Identifier: NCT01382277     History of Changes
Other Study ID Numbers: REDUCT
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: February 2011
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors