Coronary DiseasePhase 4NCT01325818
The Effects of Pravastatin and Rosuvastatin on Coronary Plaques in Patients With Stable Angina Pectoris
A Phase 4 study testing pravastatin, rosuvastatin in people with Coronary Disease and Hypercholesterolemia, run by Yokohama City University Medical Center at 1 site in Japan.
Trial summary
The purpose of this study is to compare the effects of pravastatin and rosuvastatin on coronary plaque characteristics in patients with stable angina pectoris. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Disease, Hypercholesterolemia
- What is being tested?
- pravastatin, rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2011to Feb 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been diagnosed as stable angina pectoris, and successful percutaneous coronary intervention (PCI) were performed with intravascular ultrasound (IVUS) and optical coherence tomography (OCT) guidance.
- Patients having coronary plaques (≧ 500 µm in thickness or % plaque of 20% or more at ≧ 5 mm distal or proximal to the previously treated area in the same branch of coronary artery.
- Patients with dyslipidemia as defined by any of the following criteria:
- TC ≧ 220 mg/dL
- LDL-C ≧ 140 mg/dL
- Cholesterol-lowering treatment is allowed according to the investigator's judgment when LDL-C ≧ 100 mg/dL or TC ≧ 180mg/dL.
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- Patients who are under cholesterol-lowering treatment and LDL-C ≦ 120 mg/dL
- Patients 20 years or older at the time of their consent.
- Patients with written consent by their own volition after being provided sufficient explanation for their participation in this clinical trial.
Who cannot join
- Patients with bypass graft or in-stent restenosis at the site of PCI.
- Patients who received PCI in the past on the lesion where the evaluation of coronary plaque volume is planned.
- Patients who had plaques in a non-culprit site and might receive PCI during the treatment period.
- Patients receiving lipid-lowering drugs (fibrates, probucol, nicotinic acid, cholestyramine or cholesterol absorption inhibitors).
- Patients with familial hypercholesterolemia.
- Patients with cardiogenic shock.
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- Patients receiving cyclosporine.
- Patients with any allergy to pravastatin and rosuvastatin.
- Patients with hepatobiliary disorders.
- Pregnant women, women suspected of being pregnant, or lactating women.
- Patients with renal disorders (Cr≧2.0mg/dL) or undergoing dialysis.
- Patients who are ineligible in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Yokohama City University Medical Center
Yokohama
Kenichiro Saka, 81-45-261-5656, Ken_saka@yokohama-cu.ac.jp
Kenichiro Saka
About this study
Official title: The Effects of Pravastatin and Rosuvastatin on the Tissue Characteristics and Morphology of Coronary Plaques in Patients With Stable Angina Pectoris
The purpose of this study is to compare the effects of pravastatin and rosuvastatin on coronary plaque characteristics in patients with stable angina pectoris.
Read the detailed description
Previous mega trials have demonstrated that lipid-lowering therapy with HMG-CoA reductase inhibitors in individuals with high risk of cardiovascular disease reduces the incidence of coronary heart disease. NCEP ATP-III has suggested the advantage of more intensive lipid lowering therapy with a goal of reducing LDL-C below 70 mg/dL for such patients categorized as very high risk. In Japan, Japan Atherosclerosis Society (JAS) Guidelines for Diagnosis and Treatment of Atherosclerotic Cardiovascular Diseases 2002 have recommended that an LDL-C goal for patients with coronary heart disease (CHD) should be below 100 mg/dL. However, there is no satisfactory evidence whether the investigators need to lower LDL-C level less than the 70mg/dL or not in Japanese population.
Recently, research on diagnosis of coronary plaque has shown significant advances. The REVERSAL study in patients with a history of CHD, by diagnosis with intravascular ultrasound (IVUS), suggested that intensive lipid lowering therapy with atorvastatin (80 mg/day) was associated with no growth of plaque (-0.4% compared to baseline), whereas therapy with pravastatin (40 mg/day) showed a slight increase (2.7%) in plaque volume over 18 months in Western population.
MEGA study has shown that lipid lowering therapy with pravastatin (10-20 mg/day) was associated with a 33% reduction in coronary heart disease incidence as the primary prevention in Japanese patients. However, the effect of lipid lowering therapy in secondary prevention of cardiovascular events is unknown.
Relative plaque regression rate between intensive and moderate lipid lowering therapy would clarify the ideal level of target LDL-C in Japanese population. Furthermore, the different effect on coronary plaque between pravastatin and rosuvastatin which have different LDL-C lowering effect and different affinity to arterial tissue would determine the superior lipid lowering regimen to affect coronary plaque volume.
Therefore, the aim of the present study is to evaluate whether there would be lipid lowering therapy differences in terms of the composition of coronary artery plaques in patients with stable angina pectoris (SAP) using integrated backscatter intravascular ultrasound (IB-IVUS) and optical coherence tomography (OCT).
- Conditions
- Coronary Disease, Hypercholesterolemia
- Being tested
- pravastatin, rosuvastatin
- Keywords
- Coronary Artery Disease, Coronary Disease, Dyslipidemia, Stable Angina Pectoris, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases Pravastatin, Rosuvastatin, Anticholesteremic Agents, Antilipemic Agents, Antimetabolites, Molecular Mechanisms of Pharmacological Action, Pharmacologic Actions, Therapeutic Uses, Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Medical subject headings
- Coronary Disease, Hypercholesterolemia, Coronary Artery Disease, Dyslipidemias, Angina, Stable, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pravastatin, rosuvastatinDrug
- Active Comparator Intervention: Drug: pravastatin 10mg/day or 20mg/day
- Active Comparator Intervention: Drug: rosuvastatin 20mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1:pravastatin, 2:rosuvastatin | Active comparator | 1. Active Comparator Drug:pravastatin
2. Active Comparator Drug:rosuvastatin Receives: Drug: pravastatin, rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percent change in fibrous cap thickness by optical coherence tomography
the percent change in fibrous cap thickness by optical coherence tomography
Measured: 9-11 months
Secondary outcomes (3)
the percent change and the absolute change from baseline in coronary plaque volume and IB signal obtained by IB-IVUS
the percent change and the absolute change from baseline in coronary plaque volume, the percent change in integrated backscatter signal obtained by integrated backscatter IVUS
Measured: 9-11 months
the absolute change from baseline in number of TCFA and plaque rupture, and in neointima thickness on stent struts by OCT
the absolute change from baseline in number of TCFA, plaque rupture, thrombus, calcification, and in neointima thickness on stent struts by optical coherence tomography
Measured: 9-11 months
the percent change and the absolute change from baseline in total cholesterol and LDL cholesterol
the percent change and the absolute change from baseline in total cholesterol and low-density lipoprotein cholesterol
Measured: 9-11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2011 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yokohama City University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Kiyoshi Hibi, Study chair, Yokohama City University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325818
- Sponsor's protocol ID
- YCUMC20110324
- Status last verified
- Mar 2011
- First submitted
- 28 Mar 2011
- Last updated
- 1 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pravastatin and Rosuvastatin on the Tissue Characteristics and Morphology of Coronary Plaques in Patients With Stable Angina Pectoris
- ClinicalTrials.gov ID
- NCT01325818
- Acronym / sponsor ID
- YCUMC20110324
- Conditions
- Coronary Disease, Hypercholesterolemia
- Keywords
- Coronary Artery Disease, Coronary Disease, Dyslipidemia, Stable Angina Pectoris, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yokohama City University Medical CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 30 Mar 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.
The purpose of this study is to compare the effects of pravastatin and rosuvastatin on coronary plaque characteristics in patients with stable angina pectoris.
Detailed description
Previous mega trials have demonstrated that lipid-lowering therapy with HMG-CoA reductase inhibitors in individuals with high risk of cardiovascular disease reduces the incidence of coronary heart disease. NCEP ATP-III has suggested the advantage of more intensive lipid lowering therapy with a goal of reducing LDL-C below 70 mg/dL for such patients categorized as very high risk. In Japan, Japan Atherosclerosis Society (JAS) Guidelines for Diagnosis and Treatment of Atherosclerotic Cardiovascular Diseases 2002 have recommended that an LDL-C goal for patients with coronary heart disease (CHD) should be below 100 mg/dL. However, there is no satisfactory evidence whether the investigators need to lower LDL-C level less than the 70mg/dL or not in Japanese population.
Recently, research on diagnosis of coronary plaque has shown significant advances. The REVERSAL study in patients with a history of CHD, by diagnosis with intravascular ultrasound (IVUS), suggested that intensive lipid lowering therapy with atorvastatin (80 mg/day) was associated with no growth of plaque (-0.4% compared to baseline), whereas therapy with pravastatin (40 mg/day) showed a slight increase (2.7%) in plaque volume over 18 months in Western population.
MEGA study has shown that lipid lowering therapy with pravastatin (10-20 mg/day) was associated with a 33% reduction in coronary heart disease incidence as the primary prevention in Japanese patients. However, the effect of lipid lowering therapy in secondary prevention of cardiovascular events is unknown.
Relative plaque regression rate between intensive and moderate lipid lowering therapy would clarify the ideal level of target LDL-C in Japanese population. Furthermore, the different effect on coronary plaque between pravastatin and rosuvastatin which have different LDL-C lowering effect and different affinity to arterial tissue would determine the superior lipid lowering regimen to affect coronary plaque volume.
Therefore, the aim of the present study is to evaluate whether there would be lipid lowering therapy differences in terms of the composition of coronary artery plaques in patients with stable angina pectoris (SAP) using integrated backscatter intravascular ultrasound (IB-IVUS) and optical coherence tomography (OCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1:pravastatin, 2:rosuvastatin | Active comparator | Drug: pravastatin, rosuvastatin1. Active Comparator Drug:pravastatin 2. Active Comparator Drug:rosuvastatin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who have been diagnosed as stable angina pectoris, and successful percutaneous coronary intervention (PCI) were performed with intravascular ultrasound (IVUS) and optical coherence tomography (OCT) guidance.
- Patients having coronary plaques (≧ 500 µm in thickness or % plaque of 20% or more at ≧ 5 mm distal or proximal to the previously treated area in the same branch of coronary artery.
- Patients with dyslipidemia as defined by any of the following criteria:
- Patients 20 years or older at the time of their consent.
- Patients with written consent by their own volition after being provided sufficient explanation for their participation in this clinical trial.
Key exclusion criteria (12 listed)
- Patients with bypass graft or in-stent restenosis at the site of PCI.
- Patients who received PCI in the past on the lesion where the evaluation of coronary plaque volume is planned.
- Patients who had plaques in a non-culprit site and might receive PCI during the treatment period.
- Patients receiving lipid-lowering drugs (fibrates, probucol, nicotinic acid, cholestyramine or cholesterol absorption inhibitors).
- Patients with familial hypercholesterolemia.
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 |
|---|---|---|
| pravastatin, rosuvastatin1. Active Comparator Intervention: Drug: pravastatin 10mg/day or 20mg/day 2. Active Comparator Intervention: Drug: rosuvastatin 20mg/day | Drug | 1:pravastatin, 2:rosuvastatin |
Primary outcome
the percent change in fibrous cap thickness by optical coherence tomography
Time frame: 9-11 months
the percent change in fibrous cap thickness by optical coherence tomography
3 secondary outcomes
the percent change and the absolute change from baseline in coronary plaque volume and IB signal obtained by IB-IVUS
Time frame: 9-11 months
the absolute change from baseline in number of TCFA and plaque rupture, and in neointima thickness on stent struts by OCT
Time frame: 9-11 months
the percent change and the absolute change from baseline in total cholesterol and LDL cholesterol
Time frame: 9-11 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 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.
Kiyoshi Hibi study chair
Yokohama City University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pravastatin, rosuvastatin in people with Coronary Disease and Hypercholesterolemia, run by Yokohama City University Medical Center at 1 site in Japan.
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 9 inclusion and 12 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 1 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 Kenichiro Saka (81-45-261-5656, Ken_saka@yokohama-cu.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percent change in fibrous cap thickness by optical coherence tomography (time frame: 9-11 months). 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 1 Apr 2011.