Coronary DiseasePhase 4Yokohama-ACSNCT00549926
Yokohama Assessment of Fluvastatin, Pravastatin, Pitavastatin and Atorvastatin in Acute Coronary Syndrome (Yokohama-ACS)
A Phase 4 study testing Fluvastatin, Pravastatin and Pitavastatin 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 fluvastatin, pravastatin, pitavastatin, and atorvastatin on coronary plaque volume in patients with acute coronary syndrome, and to clarify the impact of moderate and intensive lipid lowering therapy on coronary plaque volume, serum lipids, and inflammation… 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?
- Fluvastatin, Pravastatin and Pitavastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2007to Feb 2010
- 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 acute coronary syndrome, and successful percutaneous coronary intervention (PCI) were performed with intravascular ultrasound (IVUS) 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 hypercholesterolemia 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 judgement when LDL-C ≧ 100 mg/dL or TC ≧ 180 mg/dL.
- Patients with written consent by their own volition after being provided sufficient explanation for their participation in this clinical trial.
- Patients 20 years or older at the time of their consent.
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 (statins, fibrates, probucol, nicotinic acid 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, fluvastatin, pitavastatin, or atorvastatin.
- Patients with hepatobiliary disorders.
- Pregnant women, women suspected of being pregnant, or lactating women.
- Patients with renal disorders or undergoing dialysis.
- Patients who are ineligible in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the effects of fluvastatin, pravastatin, pitavastatin, and atorvastatin on coronary plaque volume in patients with acute coronary syndrome, and to clarify the impact of moderate and intensive lipid lowering therapy on coronary plaque volume, serum lipids, and inflammation markers in patients with acute coronary syndrome in Japanese.
Read the detailed description
Previous mega trials have demonstrated that lipid lowering therapy with HMG-CoA reductase inhibitors (statins) reduces the incidence of major cardiovascular events by one-third, thus, the benefit of lipid lowering therapy has been substantiated. Such a benefit is significant especially for patients with coronary heart disease (CHD). The third report of the National Cholesterol Education Program Adult Treatment Panel (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 should be below 100 mg/dL. However, there is no satisfactory evidence whether we 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, 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.
In Japanese population, MEGA study have shown the effect of moderate lipid lowering therapy in primary prevention of cardiovascular events. However, the effect of moderate lipid lowering therapy in secondary prevention of cardiovascular events is unknown.
Pravastatin and fluvastatin are the statin which has been administered in Japan for several years.
Although LDL-C lowering effect of these statins were less strong than new generation statins, their safeｔｙ profile have been well established. Fluvastatin were expected to reduce coronary plaque because of its high affinity to arterial tissue and antioxygenic effect compared with pitavastatin, but the effect on human coronary plaque has not been reported.
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 fluvastatin which have similar LDL-C lowering effect and different affinity to arterial tissue would determine the superior lipid lowering regimen to affect coronary plaque volume.
- Conditions
- Coronary Disease, Hypercholesterolemia
- Being tested
- Fluvastatin, Pravastatin, Pitavastatin, Atorvastatin
- Medical subject headings
- Coronary Disease, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluvastatinDrug
PravastatinDrug
PitavastatinDrug
AtorvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Fluvastatin |
| 2 | Active comparator | Not described Receives: Drug: Pravastatin |
| 3 | Active comparator | Not described Receives: Drug: Pitavastatin |
| 4 | Active comparator | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percent change in coronary plaque volume the percent change in integrated backscatter signal obtained by integrated backscatter IVUS
Measured: 9-11 month
Secondary outcomes (3)
absolute change from baseline in coronary plaque volume
Measured: 9-11 month
absolute and percent changes in minimal lumen diameter(MLD) and percent(%) stenosis
Measured: 9-11 month
absolute and percent changes in total cholesterol(TC);low-density lipoprotein(LDL)-cholesterol(LDL-C)
Measured: 9-11 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startOct 2007
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yokohama City University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Naohiro Komura, Principal investigator, Yokohama City University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549926
- Sponsor's protocol ID
- Yokohama-ACS
- Acronym
- Yokohama-ACS
- Status last verified
- Feb 2010
- First submitted
- 25 Oct 2007
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Matsushita K, Hibi K, Komura N, Kimura Y, Matsuzawa Y, Konishi M, Maejima N, Iwahashi N, Kosuge M, Ebina T, Tamura K, Kimura K. Impact of serum lipoprotein (a) level on coronary plaque progression and cardiovascular events in statin-treated patients with acute coronary syndrome: a yokohama-acs substudy. J Cardiol. 2020 Jul;76(1):66-72. doi: 10.1016/j.jjcc.2020.01.005. Epub 2020 Feb 7.
PubMed 32037254Hibi K, Sonoda S, Kawasaki M, Otsuji Y, Murohara T, Ishii H, Sato K, Koshida R, Ozaki Y, Sata M, Morino Y, Miyamoto T, Amano T, Morita S, Kozuma K, Kimura K, Fujiwara H; Ezetimibe-ACS Investigators. Effects of Ezetimibe-Statin Combination Therapy on Coronary Atherosclerosis in Acute Coronary Syndrome. Circ J. 2018 Feb 23;82(3):757-766. doi: 10.1253/circj.CJ-17-0598. Epub 2017 Dec 7.
PubMed 29212965
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yokohama Assessment of Fluvastatin, Pravastatin, Pitavastatin and Atorvastatin in Acute Coronary Syndrome (Yokohama-ACS)
- ClinicalTrials.gov ID
- NCT00549926
- Acronym / sponsor ID
- Yokohama-ACS / Yokohama-ACS
- Conditions
- Coronary Disease, Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yokohama City University Medical CenterUniversity, hospital or other
- Study start
- Oct 2007
- Study completion
- Feb 2010 (actual)
- First posted
- 26 Oct 2007 (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 fluvastatin, pravastatin, pitavastatin, and atorvastatin on coronary plaque volume in patients with acute coronary syndrome, and to clarify the impact of moderate and intensive lipid lowering therapy on coronary plaque volume, serum lipids, and inflammation markers in patients with acute coronary syndrome in Japanese.
Detailed description
Previous mega trials have demonstrated that lipid lowering therapy with HMG-CoA reductase inhibitors (statins) reduces the incidence of major cardiovascular events by one-third, thus, the benefit of lipid lowering therapy has been substantiated. Such a benefit is significant especially for patients with coronary heart disease (CHD). The third report of the National Cholesterol Education Program Adult Treatment Panel (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 should be below 100 mg/dL. However, there is no satisfactory evidence whether we 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, 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.
In Japanese population, MEGA study have shown the effect of moderate lipid lowering therapy in primary prevention of cardiovascular events. However, the effect of moderate lipid lowering therapy in secondary prevention of cardiovascular events is unknown.
Pravastatin and fluvastatin are the statin which has been administered in Japan for several years.
Although LDL-C lowering effect of these statins were less strong than new generation statins, their safeｔｙ profile have been well established. Fluvastatin were expected to reduce coronary plaque because of its high affinity to arterial tissue and antioxygenic effect compared with pitavastatin, but the effect on human coronary plaque has not been reported.
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 fluvastatin which have similar LDL-C lowering effect and different affinity to arterial tissue would determine the superior lipid lowering regimen to affect coronary plaque volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Fluvastatin |
| 2 | Active comparator | Drug: Pravastatin |
| 3 | Active comparator | Drug: Pitavastatin |
| 4 | Active comparator | Drug: Atorvastatin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who have been diagnosed as acute coronary syndrome, and successful percutaneous coronary intervention (PCI) were performed with intravascular ultrasound (IVUS) 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 hypercholesterolemia as defined by any of the following criteria:
- Patients with written consent by their own volition after being provided sufficient explanation for their participation in this clinical trial.
- Patients 20 years or older at the time of their consent.
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 (statins, fibrates, probucol, nicotinic acid 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 |
|---|---|---|
| Fluvastatin | Drug | 1 |
| Pravastatin | Drug | 2 |
| Pitavastatin | Drug | 3 |
| Atorvastatin | Drug | 4 |
Primary outcome
the percent change in coronary plaque volume the percent change in integrated backscatter signal obtained by integrated backscatter IVUS
Time frame: 9-11 month
3 secondary outcomes
absolute change from baseline in coronary plaque volume
Time frame: 9-11 month
absolute and percent changes in minimal lumen diameter(MLD) and percent(%) stenosis
Time frame: 9-11 month
absolute and percent changes in total cholesterol(TC);low-density lipoprotein(LDL)-cholesterol(LDL-C)
Time frame: 9-11 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2010.
- Derived from this study: PubMed 32037254Matsushita K, Hibi K, Komura N, Kimura Y, Matsuzawa Y, Konishi M, Maejima N, Iwahashi N, Kosuge M, Ebina T, Tamura K, Kimura K. Impact of serum lipoprotein (a) level on coronary plaque progression and cardiovascular events in statin-treated patients with acute coronary syndrome: a yokohama-acs substudy. J Cardiol. 2020 Jul;76(1):66-72. doi: 10.1016/j.jjcc.2020.01.005. Epub 2020 Feb 7.
- Derived from this study: PubMed 29212965Hibi K, Sonoda S, Kawasaki M, Otsuji Y, Murohara T, Ishii H, Sato K, Koshida R, Ozaki Y, Sata M, Morino Y, Miyamoto T, Amano T, Morita S, Kozuma K, Kimura K, Fujiwara H; Ezetimibe-ACS Investigators. Effects of Ezetimibe-Statin Combination Therapy on Coronary Atherosclerosis in Acute Coronary Syndrome. Circ J. 2018 Feb 23;82(3):757-766. doi: 10.1253/circj.CJ-17-0598. Epub 2017 Dec 7.
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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.
Naohiro Komura principal investigator
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 Fluvastatin, Pravastatin and Pitavastatin 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 7 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: finished, as of the sponsor's last update on 17 Feb 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percent change in coronary plaque volume the percent change in integrated backscatter signal obtained by integrated backscatter IVUS (time frame: 9-11 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00549926, which also lists 2 linked publications.
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 17 Feb 2010.