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

Primary Purpose

Coronary Disease, Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Pitavastatin
Atorvastatin
Sponsored by
Kyoto University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Acute coronary syndrome, Hypercholesterolemia, Primary coronary intervention, Hydroxymethylglutaryl-CoA reductase inhibitors, coronary plaque, Angioplasty, Transluminal, Percutaneous Coronary, Ultrasonography, Interventional

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Juntendo University School of Medicine
  • Yamaguchi University Graduate School of Medicine
  • Kyoto University Graduate School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Pitavastatin

Atorvastatin

Outcomes

Primary Outcome Measures

plaque volume

Secondary Outcome Measures

total cholesterol (TC)
low-density lipoprotein (LDL)-cholesterol (LDL-C)
high-density lipoprotein (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
apolipoprotein AI (apoA-I)
apoB
apoE
apoB/apoA-I
malondialdehyde-modified LDL (MDA-LDL)
phospholipids
lipoprotein(a) [Lp(a)]
high-sensitivity C-reactive protein (hs-CRP)
pentraxin 3
leukocytes
coronary plaque area at culprit region
minimal lumen diameter (MLD) and percent (%) 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

Full Information

First Posted
October 20, 2005
Last Updated
October 2, 2023
Sponsor
Kyoto University
Collaborators
Yamaguchi University Hospital, Juntendo University
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1. Study Identification

Unique Protocol Identification Number
NCT00242944
Brief Title
Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS)
Official Title
Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyoto University
Collaborators
Yamaguchi University Hospital, Juntendo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Hypercholesterolemia
Keywords
Acute coronary syndrome, Hypercholesterolemia, Primary coronary intervention, Hydroxymethylglutaryl-CoA reductase inhibitors, coronary plaque, Angioplasty, Transluminal, Percutaneous Coronary, Ultrasonography, Interventional

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Pitavastatin
Arm Title
2
Arm Type
Active Comparator
Arm Description
Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Intervention Description
Pitavastatin 4mg per day
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 20mg per day
Primary Outcome Measure Information:
Title
plaque volume
Time Frame
one year
Secondary Outcome Measure Information:
Title
total cholesterol (TC)
Time Frame
one year
Title
low-density lipoprotein (LDL)-cholesterol (LDL-C)
Time Frame
one year
Title
high-density lipoprotein (HDL)-cholesterol (HDL-C)
Time Frame
one year
Title
HDL2-C
Time Frame
one year
Title
HDL3-C
Time Frame
one year
Title
remnant like particles-cholesterol (RLP-C)
Time Frame
one year
Title
small dense LDL-C
Time Frame
one year
Title
non-HDL-C
Time Frame
one year
Title
LDL-C/HDL-C
Time Frame
one year
Title
apolipoprotein AI (apoA-I)
Time Frame
one year
Title
apoB
Time Frame
one year
Title
apoE
Time Frame
one year
Title
apoB/apoA-I
Time Frame
one year
Title
malondialdehyde-modified LDL (MDA-LDL)
Time Frame
one year
Title
phospholipids
Time Frame
one year
Title
lipoprotein(a) [Lp(a)]
Time Frame
one year
Title
high-sensitivity C-reactive protein (hs-CRP)
Time Frame
one year
Title
pentraxin 3
Time Frame
one year
Title
leukocytes
Time Frame
one year
Title
coronary plaque area at culprit region
Time Frame
one year
Title
minimal lumen diameter (MLD) and percent (%) stenosis
Time Frame
one year
Title
major adverse cardiac events (cardiac death, Q or non-Q myocardial infarction and target vessel revascularization)
Time Frame
one year
Title
number of deaths from any cause
Time Frame
one year
Title
frequency of adverse drug reactions
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masunori Matsuzaki, MD, PhD
Organizational Affiliation
Professor of Medicine, Department of Cardiovascular Medicine, Yamaguchi University Graduate School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hiroyuki Daida, MD
Organizational Affiliation
Professor of Medicine, Department of Cardiovascular Medicine, Juntendo University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Takeshi Kimura, MD
Organizational Affiliation
Associate Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juntendo University School of Medicine
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8421
Country
Japan
Facility Name
Yamaguchi University Graduate School of Medicine
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Kyoto University Graduate School of Medicine
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
17127811
Citation
Miyauchi K, Kimura T, Morimoto T, Nakagawa Y, Yamagishi M, Ozaki Y, Hiro T, Daida H, Matsuzaki M. Japan assessment of pitavastatin and atorvastatin in acute coronary syndrome (JAPAN-ACS): rationale and design. Circ J. 2006 Dec;70(12):1624-8. doi: 10.1253/circj.70.1624. Erratum In: Circ J. 2007 Jan;71(1):172.
Results Reference
background
PubMed Identifier
19608026
Citation
Hiro T, Kimura T, Morimoto T, Miyauchi K, Nakagawa Y, Yamagishi M, Ozaki Y, Kimura K, Saito S, Yamaguchi T, Daida H, Matsuzaki M; JAPAN-ACS Investigators. Effect of intensive statin therapy on regression of coronary atherosclerosis in patients with acute coronary syndrome: a multicenter randomized trial evaluated by volumetric intravascular ultrasound using pitavastatin versus atorvastatin (JAPAN-ACS [Japan assessment of pitavastatin and atorvastatin in acute coronary syndrome] study). J Am Coll Cardiol. 2009 Jul 21;54(4):293-302. doi: 10.1016/j.jacc.2009.04.033.
Results Reference
result
PubMed Identifier
23289728
Citation
Fukushima Y, Daida H, Morimoto T, Kasai T, Miyauchi K, Yamagishi S, Takeuchi M, Hiro T, Kimura T, Nakagawa Y, Yamagishi M, Ozaki Y, Matsuzaki M; JAPAN-ACS Investigators. Relationship between advanced glycation end products and plaque progression in patients with acute coronary syndrome: the JAPAN-ACS sub-study. Cardiovasc Diabetol. 2013 Jan 7;12:5. doi: 10.1186/1475-2840-12-5.
Results Reference
derived
PubMed Identifier
22972364
Citation
Takashima H, Ozaki Y, Morimoto T, Kimura T, Hiro T, Miyauchi K, Nakagawa Y, Yamagishi M, Daida H, Mizuno T, Asai K, Kuroda Y, Kosaka T, Kuhara Y, Kurita A, Maeda K, Amano T, Matsuzaki M; JAPAN-ACS Investigators. Clustering of metabolic syndrome components attenuates coronary plaque regression during intensive statin therapy in patients with acute coronary syndrome: the JAPAN-ACS subanalysis study. Circ J. 2012;76(12):2840-7. doi: 10.1253/circj.cj-11-1495. Epub 2012 Sep 7.
Results Reference
derived
PubMed Identifier
20684825
Citation
Ohashi T, Shibata R, Morimoto T, Kanashiro M, Ishii H, Ichimiya S, Hiro T, Miyauchi K, Nakagawa Y, Yamagishi M, Ozaki Y, Kimura T, Daida H, Murohara T, Matsuzaki M. Correlation between circulating adiponectin levels and coronary plaque regression during aggressive lipid-lowering therapy in patients with acute coronary syndrome: subgroup analysis of JAPAN-ACS study. Atherosclerosis. 2010 Sep;212(1):237-42. doi: 10.1016/j.atherosclerosis.2010.05.005. Epub 2010 May 11.
Results Reference
derived
PubMed Identifier
20467151
Citation
Hiro T, Kimura T, Morimoto T, Miyauchi K, Nakagawa Y, Yamagishi M, Ozaki Y, Kimura K, Saito S, Yamaguchi T, Daida H, Matsuzaki M; JAPAN-ACS Investigators. Diabetes mellitus is a major negative determinant of coronary plaque regression during statin therapy in patients with acute coronary syndrome--serial intravascular ultrasound observations from the Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome Trial (the JAPAN-ACS Trial). Circ J. 2010 Jun;74(6):1165-74. doi: 10.1253/circj.cj-09-0766. Epub 2010 May 12.
Results Reference
derived

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

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