Ignite Creation Date:
2024-05-06 @ 3:58 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02420899
Status:
UNKNOWN
Last Update Posted:
2015-06-09
First Post:
2015-04-13
Brief Title:
Different Doses of Rosuvastatin Therapy on Regression of Critical Coronary Atherosclerosis in ACS Patients
Sponsor:
Beijing Friendship Hospital
Organization:
Beijing Friendship Hospital
Study Overview
Official Title:
Effect of Different Doses of Rosuvastatin Therapy on Regression of Critical Coronary Atherosclerosis in Chinese ACS Patients
Status:
UNKNOWN
Status Verified Date:
2015-06
Last Known Status:
RECRUITING
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 determine whether Rosuvastatin 10mgd or 20mgd for 36 weeks can regress critical coronary atherosclerosis as determined by IVUS imaging in Chinese Acute Coronary Syndrome ACS patients
Detailed Description:
This is a prospective open-label parallel group study to evaluate the efficacy of rosuvastatin 10mgd or 20mgd on critical coronary atherosclerosis in Chinese ACS patients The anticipated duration of the study is approximately 36 weeks Patients with angiographic luminal diameter narrowing in any non-culprit site between 40-70 will be enrolled from the study site The primary efficacy parameter is the percent change of Total Atheroma Volume TAV of critical coronary atherosclerosis after 36 weeks of treatment
For inclusion in the study subjects should fulfill the following criteria
1 Provision of informed consent prior to any study specific procedures
2 18 to 75 years old ACS patients male or female
3 The angiographic luminal diameter narrowing in any non-culprit site is between 40-70
4 statin-naive defined as receiving no statin therapy within 3 monthsThe primary efficacy variable of the study is percent change of TAV from baseline after rosuvastatin 10mgd or 20mgd for 36 weeks as determined by IVUS imaging
The secondary efficacy variables are
Change of blood lipid level from baseline at 12th 24th 36nd week
Change of inflammatory markers from baseline at 36nd week
Change of Percent Atheroma Volume PAV as determined by IVUS imaging at 36nd week
For inclusion in the study subjects should fulfill the following criteria
1 Provision of informed consent prior to any study specific procedures
2 18 to 75 years old ACS patients male or female
3 The angiographic luminal diameter narrowing in any non-culprit site is between 40-70
4 statin-naive defined as receiving no statin therapy within 3 monthsThe primary efficacy variable of the study is percent change of TAV from baseline after rosuvastatin 10mgd or 20mgd for 36 weeks as determined by IVUS imaging
The secondary efficacy variables are
Change of blood lipid level from baseline at 12th 24th 36nd week
Change of inflammatory markers from baseline at 36nd week
Change of Percent Atheroma Volume PAV as determined by IVUS imaging at 36nd week
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