Rosuvastatin Effect on Reducing Coronary Atherosclerosis Plaques Volume (REDUCT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Peking University First Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT01382277
First received: June 20, 2011
Last updated: June 23, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Hyperlipidemia
Coronary Artery Disease
Drug: Rosuvastatin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Peking University First Hospital:

Primary Outcome Measures:
  • Change from baseline in coronary atherosclerosis plaque volume using a 64 slice spiral CT at 76 weeks [ Time Frame: 76 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in blood lipids at 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in hsCRP at 26 weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Carotid intima-media thickness at 76 weeks [ Time Frame: 76 weeks ] [ Designated as safety issue: No ]
  • Number of participants with adverse events and abnormal laboratory safety markers. [ Time Frame: 76 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in blood lipids at 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in blood lipids at 76 weeks [ Time Frame: 76 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in hsCRP at 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in hsCRP at 76 weeks [ Time Frame: 76 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: March 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosuvastatin 20 mg
Rosuvastatin 20 mg for 76 weeks.
Drug: Rosuvastatin
Rosuvastatin 20 mg per day for 76 weeks
Other Name: Crestor

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382277

Contacts
Contact: Jie Jiang, MD 86-10-66551383 jiangjie@medmail.com.cn

Locations
China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Yanjun Gong, MD    86-10-83572299    gongyanjun111@163.com   
China
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
Investigators
Principal Investigator: Yong Huo, MD Peking University First Hospital
  More Information

No publications provided

Responsible Party: Yong Huo, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT01382277     History of Changes
Other Study ID Numbers: REDUCT
Study First Received: June 20, 2011
Last Updated: June 23, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hyperlipidemias
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Arteriosclerosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014