HyperlipidemiaPhase 4REDUCTNCT01382277
Rosuvastatin Effect on Reducing Coronary Atherosclerosis Plaques Volume
A Phase 4 study testing Rosuvastatin in people with Hyperlipidemia and Coronary Artery Disease, run by Peking University First Hospital at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperlipidemia, Coronary Artery Disease
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2011to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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%
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- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yanjun Gong, MD, 86-10-83572299, gongyanjun111@163.com
- Recruiting
Division of Cardiology, Peking University First Hospital
Beijing, 100034
Jie Jiang, MD, 86-10-66551383
About this study
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
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.
- Conditions
- Hyperlipidemia, Coronary Artery Disease
- Being tested
- Rosuvastatin
- Medical subject headings
- Hyperlipidemias, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
Rosuvastatin 20 mg per day for 76 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin 20 mg | Experimental | Rosuvastatin 20 mg for 76 weeks. Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in coronary atherosclerosis plaque volume using a 64 slice spiral CT at 76 weeks
Measured: 76 weeks
Secondary outcomes (8)
Change from baseline in blood lipids at 26 weeks
Measured: 26 weeks
Change from baseline in hsCRP at 26 weeks
Measured: 26 weeks
Change from baseline in Carotid intima-media thickness at 76 weeks
Measured: 76 weeks
Number of participants with adverse events and abnormal laboratory safety markers.
Measured: 76 weeks
Change from baseline in blood lipids at 52 weeks
Measured: 52 weeks
Change from baseline in blood lipids at 76 weeks
Measured: 76 weeks
Change from baseline in hsCRP at 52 weeks
Measured: 52 weeks
Change from baseline in hsCRP at 76 weeks
Measured: 76 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yong Huo, MD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382277
- Sponsor's protocol ID
- REDUCT
- Acronym
- REDUCT
- Status last verified
- Feb 2011
- First submitted
- 20 Jun 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01382277
- Acronym / sponsor ID
- REDUCT / REDUCT
- Conditions
- Hyperlipidemia, Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin 20 mg | Experimental | Drug: RosuvastatinRosuvastatin 20 mg for 76 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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:
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: CrestorRosuvastatin 20 mg per day for 76 weeks | Drug | Rosuvastatin 20 mg |
Primary outcome
Change from baseline in coronary atherosclerosis plaque volume using a 64 slice spiral CT at 76 weeks
Time frame: 76 weeks
8 secondary outcomes
Change from baseline in blood lipids at 26 weeks
Time frame: 26 weeks
Change from baseline in hsCRP at 26 weeks
Time frame: 26 weeks
Change from baseline in Carotid intima-media thickness at 76 weeks
Time frame: 76 weeks
Number of participants with adverse events and abnormal laboratory safety markers.
Time frame: 76 weeks
Change from baseline in blood lipids at 52 weeks
Time frame: 52 weeks
Change from baseline in blood lipids at 76 weeks
Time frame: 76 weeks
Change from baseline in hsCRP at 52 weeks
Time frame: 52 weeks
Change from baseline in hsCRP at 76 weeks
Time frame: 76 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Huo, MD principal investigator
Peking University First Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin in people with Hyperlipidemia and Coronary Artery Disease, run by Peking University First Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Jiang, MD (86-10-66551383, jiangjie@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in coronary atherosclerosis plaque volume using a 64 slice spiral CT at 76 weeks (time frame: 76 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.