Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00242944
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : December 17, 2009
Sponsor:
Collaborators:
Yamaguchi University Hospital
Juntendo University
Information provided by:
Kyoto University

Tracking Information
First Submitted Date  ICMJE October 20, 2005
First Posted Date  ICMJE October 21, 2005
Last Update Posted Date December 17, 2009
Study Start Date  ICMJE November 2005
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2007)
plaque volume [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2005)
plaque volume
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2007)
  • total cholesterol (TC) [ Time Frame: one year ]
  • low-density lipoprotein (LDL)-cholesterol (LDL-C) [ Time Frame: one year ]
  • high-density lipoprotein (HDL)-cholesterol (HDL-C) [ Time Frame: one year ]
  • HDL2-C [ Time Frame: one year ]
  • HDL3-C [ Time Frame: one year ]
  • remnant like particles-cholesterol (RLP-C) [ Time Frame: one year ]
  • small dense LDL-C [ Time Frame: one year ]
  • non-HDL-C [ Time Frame: one year ]
  • LDL-C/HDL-C [ Time Frame: one year ]
  • apolipoprotein AI (apoA-I) [ Time Frame: one year ]
  • apoB [ Time Frame: one year ]
  • apoE [ Time Frame: one year ]
  • apoB/apoA-I [ Time Frame: one year ]
  • malondialdehyde-modified LDL (MDA-LDL) [ Time Frame: one year ]
  • phospholipids [ Time Frame: one year ]
  • lipoprotein(a) [Lp(a)] [ Time Frame: one year ]
  • high-sensitivity C-reactive protein (hs-CRP) [ Time Frame: one year ]
  • pentraxin 3 [ Time Frame: one year ]
  • leukocytes [ Time Frame: one year ]
  • coronary plaque area at culprit region [ Time Frame: one year ]
  • minimal lumen diameter (MLD) and percent (%) stenosis [ Time Frame: one year ]
  • major adverse cardiac events (cardiac death, Q or non-Q myocardial infarction and target vessel revascularization) [ Time Frame: one year ]
  • number of deaths from any cause [ Time Frame: one year ]
  • frequency of adverse drug reactions [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2005)
  • total cholesterol (TC)
  • LDL-cholesterol (LDL-C)
  • HDL-cholesterol (HDL-C)
  • HDL2-C
  • HDL3-C
  • remnant like particles-cholesterol (RLP-C)
  • small dense LDL-C
  • non-HDL-C
  • LDL-C/HDL-C
  • apoA-I
  • apoB
  • apoE
  • apoB/apoA-I
  • malondialdehyde-modified LDL (MDA-LDL)
  • phospholipids
  • lipoprotein(a) (Lp(a))
  • hs-CRP
  • pentraxin 3
  • leukocytes
  • coronary plaque area at culprit region
  • minimal lumen diameter (MLD) and %stenosis
  • major adverse cardiac events (cardiac death, Q or non-Q myocardial infarction and target vessel revascularization)
  • number of deaths from any cause
  • frequency of adverse drug reactions
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS)
Official Title  ICMJE Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome
Brief Summary The purpose of this study is to compare the effects of pitavastatin and atorvastatin on coronary plaque volume in patients with acute coronary syndrome and to clarify the relationship between coronary plaque volume, serum lipids, and inflammation markers in order to determine the significance of intensive lipid lowering therapy in patients with acute coronary syndrome in Japan.
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 yet for the need to lower LDL-C level less than the goal prescribed in Japan.

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), versus therapy with pravastatin (40 mg/day) which showed a slight increase (2.7%) in plaque volume over 18 months. In Japan, the ESTABLISH study, a single center study, indicated that early intensive lipid lowering therapy with atorvastatin (20 mg/day) could induce a significant reduction in plaque volume in patients with acute coronary syndrome. However, this benefit has not been verified in multicenter trials in Japan. Further, no comparative investigation into the effect of various concomitant drugs on coronary plaque has been done.

Pitavastatin is a chemically synthesized statin in Japan which has been marketed since late 2003. Pitavastatin has an LDL-C lowering effect as strong as atorvastatin and also has a superior HDL-C elevating effect; meanwhile, the effect of pitavastatin on coronary plaque has not been reported.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Disease
  • Hypercholesterolemia
Intervention  ICMJE
  • Drug: Pitavastatin
    Pitavastatin 4mg per day
  • Drug: Atorvastatin
    Atorvastatin 20mg per day
Study Arms  ICMJE
  • Active Comparator: 1
    Pitavastatin
    Intervention: Drug: Pitavastatin
  • Active Comparator: 2
    Atorvastatin
    Intervention: Drug: Atorvastatin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2008)
307
Original Enrollment  ICMJE
 (submitted: October 20, 2005)
300
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00242944
Other Study ID Numbers  ICMJE H17-49
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Masunori Matsuzaki, Yamaguchi University Graduate School of Medicine
Study Sponsor  ICMJE Kyoto University
Collaborators  ICMJE
  • Yamaguchi University Hospital
  • Juntendo University
Investigators  ICMJE
Study Chair: Masunori Matsuzaki, MD, PhD Professor of Medicine, Department of Cardiovascular Medicine, Yamaguchi University Graduate School of Medicine
Principal Investigator: Hiroyuki Daida, MD Professor of Medicine, Department of Cardiovascular Medicine, Juntendo University School of Medicine
Principal Investigator: Takeshi Kimura, MD Associate Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
PRS Account Kyoto University
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP