StatinEx JAPAN-ACSNCT01223586

Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome

An observational study of Statin and Coronary Plaque, run by Kyoto University at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this study is to verify the relationship between coronary plaque regression and cardiovascular prevention in long term follow up of the Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS) study [NCT00242944]. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Statin, Coronary Plaque, Acute Coronary Syndrome
How many people: 238 participants
Where: 2 sitesJapan
Study dates: Nov 2010to May 2011
Phase: Observational
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

Study population: Cohort of participants of JAPAN-ACS trial who completed the study

Who may be able to join

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
Patients with hypercholesterolemia as defined by any of the following criteria:
TC >= 220 mg/dL; LDL-C >= 140 mg/dL; Cholesterol-lowering treatment is necessary in accordance with the investigator's judgement when LDL-C >= 100 mg/dL or TC >= 180 mg/dL.
Patients who have been diagnosed with acute coronary syndrome
Patients with successful percutaneous coronary intervention (PCI) by intravascular ultrasound (IVUS) guidance
Patients having coronary plaques (>= 500 µm in thickness or 20% or more in % plaque) at >= 5 mm from the previously treated area in the same branch of coronary artery

Who cannot join

Patients with bypass graft or in-stent restenosis at the site of PCI
Patients who had received PCI on the lesion in the past 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

Show all 12Show fewer

Patients receiving cyclosporine
Patients with any allergy to 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

2 sites in 1 country.

Japan2 sites

Division of Cardiology, Kyoto University Hospital
Kyoto, Kyoto, 606-8507
Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine
Ube, Yamaguchi, 755-8505

Other trials in Japan

About this study

Read the detailed description

Several previous multicenter studies using intravascular ultrasound (IVUS) imaging have revealed that statins attenuate the progression of atherosclerosis or even provide regression of plaque volume. Indeed, the Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS) trial [NCT00242944] has revealed that early aggressive statin therapy in patients with acute coronary syndrome (ACS) significantly reduces the plaque volume of non-culprit coronary lesions On the other hands, a direct relationship between atheroma progression and regression on IVUS and clinical events has not been clearly defined. To verify that relationship, long term follow up of the JAPAN-ACS study will be performed. Clinical outcome of patients with regressed plaque and progressed plaque will be compared. In addition, the objectives of this study are to evaluate the effect of serum lipid levels or different type of statins on cardiovascular prevention.

Conditions: Statin, Coronary Plaque, Acute Coronary Syndrome, Intravascular Ultrasound, Cardiovascular Events
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01223586
Study group	Role	What they receive
Regression		Patients with regression of plaque volume by statin
Non regression		Patients without regression of plaque volume by statin

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite endpoint
Occurrence of one of following events:
Cardiovascular death (death from cardiac cause or stroke or peripheral artery disease) Non-fatal Myocardial Infarction (MI) Non-fatal Cerebral Infarction (CI) except for transient ischemic attack (TIA) Unstable angina requiring urgent hospitalizations
Measured: 4-year

Secondary outcomes (7)

Composite cardiovascular events
Occurrence of one of following events:
Cardiovascular death Non-fatal MI Non-fatal CI Unstable angina requiring hospitalizations Ischemia-driven coronary revascularization except target lesion revascularization (TLR)
Measured: 4-year
Composite coronary heart disease events
Occurrence of one of following events:
Coronary heart disease (CHD) death Non-fatal MI Unstable angina requiring urgent hospitalizations Ischemia-driven coronary revascularization except TLR
Measured: 4-year
Composite cerebrovascular events
Occurrence of one of following events:
Fatal and Non-fatal stroke Transient ischemic attack requiring hospitalizations
Measured: 4-year
Mortality
Occurrence of each following events:
All-cause mortality Cardiovascular death Cardiac death (death from coronary disease or heart failure or arrhythmia and sudden death) CHD death (death from myocardial infarction and sudden death)
Measured: 4-year
Heart disease events
Occurrence of each following events:
Fatal and Non-fatal MI Non-procedure related MI Procedure related MI Unstable angina requiring urgent hospitalizations Resuscitated cardiac arrest Hospitalization for heart failure PCI or CABG
1. All events of PCI or CABG
2. TLR
3. non-TLR
4. Ischemia-driven PCI or CABG
5. TLR
6. non-TLR
Measured: 4-year
Cerebrovascular events
Occurrence of each following events:
Fatal and Non-fatal stroke Fatal and Non-fatal CI
1. Non-procedure related CI
2. Procedure related CI Fatal and Non-fatal cerebral hemorrhage Hospitalization for TIA
Measured: 4-year
Other events
Occurrence of each following events:
Operation for or rupture of aortic aneurysm Revascularization for peripheral arterial disease (PAD) Carotid artery stenting (CAS) or carotid endarterectomy (CEA) Aortic dissection Deep vein thrombosis (DVT) or pulmonary thromboembolism (PTE) New occurrence of malignant tumor Operation for aortic stenosis
Measured: 4-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010May 2011

First posted19 Oct 2010 (estimated)
Study startNov 2010
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StatinStudies 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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 238 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01223586
Sponsor's protocol ID: H22-42
Acronym: Ex JAPAN-ACS
Status last verified: Apr 2012
First submitted: 18 Oct 2010
Last updated: 24 Apr 2012
Results posted: No
Data monitoring committee: No

Publications

Miyauchi K, Daida H, Morimoto T, Hiro T, Kimura T, Nakagawa Y, Yamagishi M, Ozaki Y, Kadota K, Kimura K, Hirayama A, Kimura K, Hasegawa Y, Uchiyama S, Matsuzaki M; JAPAN-ACS Investigators. Reverse vessel remodeling but not coronary plaque regression could predict future cardiovascular events in ACS patients with intensive statin therapy--the extended JAPAN-ACS study. Circ J. 2012;76(4):825-32. doi: 10.1253/circj.cj-12-0135.
PubMed 22451449

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
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Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
Not yet recruiting
EHR Nudges: Optimizing a Clinical Decision Support System for Evidence-Based Statin Medication Prescribing to Reduce the Risk of Cardiovascular Disease
Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Efficacy of Statins Among Major Depressive Disorder
Major Depressive Disorder, MDD

All Statin trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome
ClinicalTrials.gov ID: NCT01223586
Acronym / sponsor ID: Ex JAPAN-ACS / H22-42
Conditions: Statin, Coronary Plaque, Acute Coronary Syndrome, Intravascular Ultrasound, Cardiovascular Events
Study type: Observational
Recruitment status: Completed
Enrolment: 238 participants (actual)
Lead sponsor: Kyoto UniversityUniversity, hospital or other
Collaborators: Yamaguchi University Hospital
Study start: Nov 2010
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 19 Oct 2010 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Regression	–	–Patients with regression of plaque volume by statin
Non regression	–	–Patients without regression of plaque volume by statin

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Cohort of participants of JAPAN-ACS trial who completed the study

Key inclusion criteria (7 listed)

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
Patients with hypercholesterolemia as defined by any of the following criteria:
TC >= 220 mg/dL; LDL-C >= 140 mg/dL; Cholesterol-lowering treatment is necessary in accordance with the investigator's judgement when LDL-C >= 100 mg/dL or TC >= 180 mg/dL.
Patients who have been diagnosed with acute coronary syndrome

Key exclusion criteria (12 listed)

Patients with bypass graft or in-stent restenosis at the site of PCI
Patients who had received PCI on the lesion in the past 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.

Primary outcome

Composite endpoint
Time frame: 4-year
Occurrence of one of following events: Cardiovascular death (death from cardiac cause or stroke or peripheral artery disease) Non-fatal Myocardial Infarction (MI) Non-fatal Cerebral Infarction (CI) except for transient ischemic attack (TIA) Unstable angina requiring urgent hospitalizations

7 secondary outcomes

Composite cardiovascular events
Time frame: 4-year
Composite coronary heart disease events
Time frame: 4-year
Composite cerebrovascular events
Time frame: 4-year
Mortality
Time frame: 4-year
Heart disease events
Time frame: 4-year
Cerebrovascular events
Time frame: 4-year
Other events
Time frame: 4-year

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 24 Apr 2012.
Results publication: PubMed 22451449Miyauchi K, Daida H, Morimoto T, Hiro T, Kimura T, Nakagawa Y, Yamagishi M, Ozaki Y, Kadota K, Kimura K, Hirayama A, Kimura K, Hasegawa Y, Uchiyama S, Matsuzaki M; JAPAN-ACS Investigators. Reverse vessel remodeling but not coronary plaque regression could predict future cardiovascular events in ACS patients with intensive statin therapy--the extended JAPAN-ACS study. Circ J. 2012;76(4):825-32. doi: 10.1253/circj.cj-12-0135.

Related trials for Statin

Not yet recruitingPhase 2
Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
Dyslipidemia
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
Not yet recruiting
EHR Nudges: Optimizing a Clinical Decision Support System for Evidence-Based Statin Medication Prescribing to Reduce the Risk of Cardiovascular Disease
Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Efficacy of Statins Among Major Depressive Disorder
Major Depressive Disorder, MDD

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.

Masunori Matsuzaki, MD, PhD principal investigator

Professor of Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Statin and Coronary Plaque, run by Kyoto University at 2 sites 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 24 Apr 2012. 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 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.

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?

Composite endpoint (time frame: 4-year). 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 NCT01223586, which also lists 1 linked publication.

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 24 Apr 2012.