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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • 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:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

    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 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rosuvastatin 20 mg
Rosuvastatin 20 mg for 76 weeks.
Drug: Rosuvastatin
Rosuvastatin 20 mg per day for 76 weeks
Other Names:
  • Crestor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University First Hospital

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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