Ignite Creation Date:
2024-05-05 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00549926
Status:
COMPLETED
Last Update Posted:
2010-02-17
First Post:
2007-10-25
Brief Title:
Yokohama Assessment of Fluvastatin Pravastatin Pitavastatin and Atorvastatin in Acute Coronary Syndrome Yokohama-ACS
Sponsor:
Yokohama City University Medical Center
Organization:
Yokohama City University Medical Center
Study Overview
Official Title:
Yokohama Assessment of Fluvastatin Pravastatin Pitavastatin and Atorvastatin in Acute Coronary Syndrome Yokohama-ACS
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Yokohama-ACS
Brief Summary:
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
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 mgdL 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 mgdL However there is no satisfactory evidence whether we need to lower LDL-C level less than the 70mgdL 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 mgday was associated with no growth of plaque -04 compared to baseline whereas therapy with pravastatin 40 mgday showed a slight increase 27 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
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 mgday was associated with no growth of plaque -04 compared to baseline whereas therapy with pravastatin 40 mgday showed a slight increase 27 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None