Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242944
Status:
COMPLETED
Last Update Posted:
2023-10-04
First Post:
2005-10-20
Brief Title:
Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome JAPAN-ACS
Sponsor:
Kyoto University
Organization:
Kyoto University
Study Overview
Official Title:
Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2023-10
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:
None
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 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 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 mgday was associated with no growth of plaque -04 compared to baseline versus therapy with pravastatin 40 mgday which showed a slight increase 27 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 mgday 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
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 versus therapy with pravastatin 40 mgday which showed a slight increase 27 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 mgday 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
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