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Sponsors and Collaborators: |
Kyoto University Yamaguchi University Hospital Juntendo University School of Medicine |
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Information provided by: | Kyoto University |
ClinicalTrials.gov Identifier: | NCT00242944 |
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.
Condition | Intervention | Phase |
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Coronary Disease Hypercholesterolemia |
Drug: Pitavastatin Drug: Atorvastatin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome |
Enrollment: | 307 |
Study Start Date: | November 2005 |
Study Completion Date: | March 2008 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Pitavastatin
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Drug: Pitavastatin
Pitavastatin 4mg per day
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2: Active Comparator
Atorvastatin
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Drug: Atorvastatin
Atorvastatin 20mg per day
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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.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with hypercholesterolemia as defined by any of the following criteria:
Exclusion Criteria:
Japan | |
Kyoto University Graduate School of Medicine | |
Kyoto, Japan, 606-8507 | |
Japan, Tokyo | |
Juntendo University School of Medicine | |
Bunkyo-ku, Tokyo, Japan, 113-8421 | |
Japan, Yamaguchi | |
Yamaguchi University Graduate School of Medicine | |
Ube, Yamaguchi, Japan, 755-8505 |
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 |
Responsible Party: | Yamaguchi University Graduate School of Medicine ( Masunori Matsuzaki ) |
Study ID Numbers: | H17-49 |
Study First Received: | October 20, 2005 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00242944 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Acute coronary syndrome Hypercholesterolemia Primary coronary intervention Hydroxymethylglutaryl-CoA reductase inhibitors |
coronary plaque Angioplasty, Transluminal, Percutaneous Coronary Ultrasonography, Interventional |
Antimetabolites Arterial Occlusive Diseases Heart Diseases Hyperlipidemias Metabolic Diseases Antilipemic Agents Myocardial Ischemia Vascular Diseases Anticholesteremic Agents Ischemia Arteriosclerosis |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Coronary Disease NK 104 Acute Coronary Syndrome Metabolic Disorder Hypercholesterolemia Atorvastatin Coronary Artery Disease Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Arteriosclerosis Pathologic Processes NK 104 Therapeutic Uses Syndrome Cardiovascular Diseases Hypercholesterolemia Dyslipidemias Arterial Occlusive Diseases Hyperlipidemias Heart Diseases |
Metabolic Diseases Disease Antilipemic Agents Vascular Diseases Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Coronary Disease Acute Coronary Syndrome Coronary Artery Disease Atorvastatin Lipid Metabolism Disorders |