- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01382277
Rosuvastatin Effect on Reducing Coronary Atherosclerosis Plaques Volume (REDUCT)
June 23, 2011 updated by: Peking University First Hospital
Rosuvastatin Effect on Reducing Coronary Atherosclerosis Plaques Volume Evaluated by Multi-slice Spiral CT in Patients With Stable Coronary Heart Disease and Hyperlipidemia
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jie Jiang, MD
- Phone Number: 86-10-66551383
- Email: jiangjie@medmail.com.cn
Study Locations
-
-
-
Beijing, China, 100034
- Recruiting
- Division of Cardiology, Peking University First Hospital
-
Contact:
- Jie Jiang, MD
- Phone Number: 86-10-66551383
-
-
Beijing
-
Beijing, Beijing, China, 100034
- Recruiting
- Peking University First Hospital
-
Contact:
- Yanjun Gong, MD
- Phone Number: 86-10-83572299
- Email: gongyanjun111@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- History of myocardial infarction.
- CHD confirmed by coronary angiography.
- Excercise ECG positive for CHD or perfusion defect
- 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:
- Diameter of coronary artery lesion ≥2mm, length ≥5mm; distance between multiple lesions >1cm
- Plaque density <100HU, no calcification
- Vascular stenosis (20~60%) caused by plaques
- Plaque thickness >1mm
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rosuvastatin 20 mg
Rosuvastatin 20 mg for 76 weeks.
|
Rosuvastatin 20 mg per day for 76 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in coronary atherosclerosis plaque volume using a 64 slice spiral CT at 76 weeks
Time Frame: 76 weeks
|
76 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in blood lipids at 26 weeks
Time Frame: 26 weeks
|
26 weeks
|
Change from baseline in hsCRP at 26 weeks
Time Frame: 26 weeks
|
26 weeks
|
Change from baseline in Carotid intima-media thickness at 76 weeks
Time Frame: 76 weeks
|
76 weeks
|
Number of participants with adverse events and abnormal laboratory safety markers.
Time Frame: 76 weeks
|
76 weeks
|
Change from baseline in blood lipids at 52 weeks
Time Frame: 52 weeks
|
52 weeks
|
Change from baseline in blood lipids at 76 weeks
Time Frame: 76 weeks
|
76 weeks
|
Change from baseline in hsCRP at 52 weeks
Time Frame: 52 weeks
|
52 weeks
|
Change from baseline in hsCRP at 76 weeks
Time Frame: 76 weeks
|
76 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Anticipated)
April 1, 2013
Study Completion (Anticipated)
April 1, 2013
Study Registration Dates
First Submitted
June 20, 2011
First Submitted That Met QC Criteria
June 23, 2011
First Posted (Estimate)
June 27, 2011
Study Record Updates
Last Update Posted (Estimate)
June 27, 2011
Last Update Submitted That Met QC Criteria
June 23, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Lipid Metabolism Disorders
- Dyslipidemias
- Coronary Artery Disease
- Myocardial Ischemia
- Atherosclerosis
- Hyperlipidemias
- Hyperlipoproteinemias
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
Other Study ID Numbers
- REDUCT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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