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Sponsored by: |
Yokohama City University Medical Center |
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Information provided by: | Yokohama City University Medical Center |
ClinicalTrials.gov Identifier: | NCT00549926 |
The purpose of this study is to compare the effects of fluvastatin, pravastatin, pitavastatin, and atorvastatin on coronary plaque volume in patients with acute coronary syndrome, and to clarify the impact of moderate and intensive lipid lowering therapy on coronary plaque volume, serum lipids, and inflammation markers in patients with acute coronary syndrome in Japanese.
Condition | Intervention | Phase |
---|---|---|
Coronary Disease Hypercholesterolemia |
Drug: Fluvastatin Drug: Pravastatin Drug: Pitavastatin Drug: Atorvastatin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Yokohama Assessment of Fluvastatin, Pravastatin, Pitavastatin and Atorvastatin in Acute Coronary Syndrome (Yokohama-ACS) |
Estimated Enrollment: | 200 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | June 2009 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator | Drug: Fluvastatin |
2: Active Comparator | Drug: Pravastatin |
3: Active Comparator | Drug: Pitavastatin |
4: Active Comparator | Drug: Atorvastatin |
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 whether we need to lower LDL-C level less than the 70mg/dL or not in Japanese population. 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), whereas therapy with pravastatin (40 mg/day) showed a slight increase (2.7%) in plaque volume over 18 months in Western population. In Japanese population, MEGA study have shown the effect of moderate lipid lowering therapy in primary prevention of cardiovascular events. However, the effect of moderate lipid lowering therapy in secondary prevention of cardiovascular events is unknown.
Pravastatin and fluvastatin are the statin which has been administered in Japan for several years.
Although LDL-C lowering effect of these statins were less strong than new generation statins, their safety profile have been well established.
Fluvastatin were expected to reduce coronary plaque because of its high affinity to arterial tissue and antioxygenic effect compared with pitavastatin, but the effect on human coronary plaque has not been reported. Relative plaque regression rate between intensive and moderate lipid lowering therapy would clarify the ideal level of target LDL-C in Japanese population. Furthermore, the different effect on coronary plaque between pravastatin and fluvastatin which have similar LDL-C lowering effect and different affinity to arterial tissue would determine the superior lipid lowering regimen to affect coronary plaque volume.
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:
Contact: Naohiro Komura | 81452615656 | |
Contact: Kiyoshi Hibi | 81452615656 |
Japan | |
Yokohama City University Medical Center | Recruiting |
Yokohama, Japan | |
Contact: Naohiro Komura 81452615656 |
Principal Investigator: | Naohiro Komura | Yokohama City University Medical Center |
Study ID Numbers: | Yokohama-ACS |
Study First Received: | October 25, 2007 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00549926 History of Changes |
Health Authority: | Japan: Institutional Review Board |
Antimetabolites Arterial Occlusive Diseases Heart Diseases Hyperlipidemias Metabolic Diseases Antilipemic Agents Myocardial Ischemia Vascular Diseases Anticholesteremic Agents Ischemia Arteriosclerosis Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Fluvastatin Coronary Disease Pravastatin 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 Pravastatin NK 104 Therapeutic Uses Cardiovascular Diseases Hypercholesterolemia Dyslipidemias Arterial Occlusive Diseases Hyperlipidemias Heart Diseases |
Metabolic Diseases Antilipemic Agents Vascular Diseases Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Fluvastatin Pharmacologic Actions Coronary Disease Acute Coronary Syndrome Coronary Artery Disease Atorvastatin Lipid Metabolism Disorders |