Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (Ex JAPAN-ACS)

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]. In addition, the effect of serum lipid levels or different type of statins on cardiovascular prevention will also be examined.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome; Cardiovascular Events; Statin; Intravascular Ultrasound; Coronary Plaque

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.

• Study Type: Observational
• Enrollment (Actual): 238

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cohort of participants of JAPAN-ACS trial who completed the study

Description

At the enrollment of original study

Inclusion 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
• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Regression; Patients with regression of plaque volume by statin
Non regression; Patients without regression of plaque volume by statin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	4-year
Composite cerebrovascular events	Occurrence of one of following events: Fatal and Non-fatal stroke Transient ischemic attack requiring hospitalizations	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)	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; All events of PCI or CABGTLRnon-TLR; Ischemia-driven PCI or CABGTLRnon-TLR	4-year
Cerebrovascular events	Occurrence of each following events: Fatal and Non-fatal stroke Fatal and Non-fatal CI; Non-procedure related CI; Procedure related CI Fatal and Non-fatal cerebral hemorrhage Hospitalization for TIA	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	4-year

Collaborators and Investigators

• Sponsor: Kyoto University
• Collaborators: Yamaguchi University Hospital
• Investigators: Principal Investigator: Masunori Matsuzaki, MD, PhD, Professor of Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: October 18, 2010
• First Submitted That Met QC Criteria: October 18, 2010
• First Posted (Estimate): October 19, 2010

Study Record Updates

• Last Update Posted (Estimate): April 24, 2012
• Last Update Submitted That Met QC Criteria: April 21, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: H22-42