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

NCT00242944 | Completed Phase 4 DMC

• 1 other identifier: H17-49
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 3

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.

Conditions

Coronary Disease; Hypercholesterolemia

Keywords

Acute coronary syndrome; Hypercholesterolemia; Primary coronary intervention; Hydroxymethylglutaryl-CoA reductase inhibitors; coronary plaque; Angioplasty, Transluminal, Percutaneous Coronary; Ultrasonography, Interventional

Outcome Measures

Primary Outcomes (1)

• plaque volume

  one year

Secondary Outcomes (24)

• total cholesterol (TC)

  one year

• low-density lipoprotein (LDL)-cholesterol (LDL-C)

  one year

• high-density lipoprotein (HDL)-cholesterol (HDL-C)

  one year

• HDL2-C

  one year

• HDL3-C

  one year

Study Arms (2)

1

ACTIVE COMPARATOR

Pitavastatin

Drug: Pitavastatin

2

ACTIVE COMPARATOR

Atorvastatin

Drug: Atorvastatin

Interventions

Pitavastatin DRUG

Pitavastatin 4mg per day

1

Atorvastatin DRUG

Atorvastatin 20mg per day

2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyoto University: lead
• Yamaguchi University Hospital: collaborator
• Juntendo University: collaborator

Study Sites (3)

Juntendo University School of Medicine

Bunkyo-ku, Tokyo, 113-8421, Japan

Location

Yamaguchi University Graduate School of Medicine

Ube, Yamaguchi, 755-8505, Japan

Location

Kyoto University Graduate School of Medicine

Kyoto, 606-8507, Japan

Location

Related Publications (6)

• 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.

  PMID: 17127811 BACKGROUND

• 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.

  PMID: 19608026 RESULT

• 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.

  PMID: 23289728 DERIVED

• 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.

  PMID: 22972364 DERIVED

• 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.

  PMID: 20684825 DERIVED

• 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.

  PMID: 20467151 DERIVED

MeSH Terms

Conditions

Coronary Disease; Hypercholesterolemia; Acute Coronary Syndrome

Interventions

pitavastatin; Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Masunori Matsuzaki, MD, PhD

  Professor of Medicine, Department of Cardiovascular Medicine, Yamaguchi University Graduate School of Medicine

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: October 20, 2005
• First Posted: October 21, 2005
• Study Start: November 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: March 1, 2008
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

JP (3)