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

Sponsor
Kyoto University (Other)
Overall Status
Completed
CT.gov ID
NCT01223586
Collaborator
Yamaguchi University Hospital (Other)
238
Enrollment
2
Locations
5.9
Duration (Months)
119
Patients Per Site
20
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    238 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome
    Study Start Date :
    Nov 1, 2010
    Actual Primary Completion Date :
    May 1, 2011
    Actual Study Completion Date :
    May 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Regression

    Patients with regression of plaque volume by statin
    Non regression

    Patients without regression of plaque volume by statin

    Outcome Measures

    Primary Outcome Measures

    1. Composite endpoint [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

    Secondary Outcome Measures

    1. Composite cardiovascular events [4-year]

      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)

    2. Composite coronary heart disease events [4-year]

      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

    3. Composite cerebrovascular events [4-year]

      Occurrence of one of following events: Fatal and Non-fatal stroke Transient ischemic attack requiring hospitalizations

    4. Mortality [4-year]

      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)

    5. Heart disease events [4-year]

      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 CABG TLR non-TLR Ischemia-driven PCI or CABG TLR non-TLR

    6. Cerebrovascular events [4-year]

      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

    7. Other events [4-year]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine Ube Yamaguchi Japan 755-8505
    2 Division of Cardiology, Kyoto University Hospital Kyoto Japan 606-8507

    Sponsors and Collaborators

    • Kyoto University
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Takeshi Morimoto, Professor of Medicine, Kyoto University
    ClinicalTrials.gov Identifier:
    NCT01223586
    Other Study ID Numbers:
    • H22-42
    First Posted:
    Oct 19, 2010
    Last Update Posted:
    Apr 24, 2012
    Last Verified:
    Apr 1, 2012
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Syndrome

    Study Results

    No Results Posted as of Apr 24, 2012