Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128024
Status:
COMPLETED
Last Update Posted:
2013-04-18
First Post:
2005-08-08
Brief Title:
Effects of Early Statin Treatment After Acute Myocardial Infarction AMI in Japanese Patients
Sponsor:
Kumamoto University
Organization:
Kumamoto University
Study Overview
Official Title:
Effects of Early Statin Treatment on Symptomatic Heart Failure and Ischemic Events After Acute Myocardial Infarction The MUSASHI-AMI A Multicenter Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2013-04
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:
Statins have been shown to prevent coronary artery disease and to preserve left ventricular function in dilated cardiomyopathy The investigators hypothesized that the early use of statins would reduce cardiovascular events including heart failure in acute myocardial infarction patients The purpose of this study is to determine whether early within 96 hours after onset use of any available statins are effective to prevent cardiovascular events including heart failure after acute myocardial infarction in Japanese patients
Detailed Description:
At least in Japanese it was controversial if lipid-lowering therapy to the patients whose total cholesterol levels 240 mgdL was needed Furthermore in general a role for early statin therapy in patients with ST-elevated AMI reperfused by primary PCI has not been clearly established Statins have been shown to prevent coronary artery disease and to preserve left ventricular function in dilated cardiomyopathy The investigators hypothesized that the early use of statins would reduce cardiovascular events including heart failure in acute myocardial infarction patients A prospective randomized open-label multicenter trial is conducted in AMI patients with normal total cholesterol levels 180-240 mgdL Patients are randomly assigned to receive any available statin within 96 hours of AMI onset or no statin and were followed for up to 24 months The primary endpoint is a composite of cardiovascular death nonfatal AMI recurrent symptomatic myocardial ischemia congestive heart failure and stroke
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KUMSEC-2001-035 | None | None | None |