Ignite Creation Date:
2024-05-05 @ 9:59 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01004406
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2009-10-29
Brief Title:
Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen PREMIER Phase I
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen PREMIER
Status:
COMPLETED
Status Verified Date:
2019-07
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:
PREMIER
Brief Summary:
The purpose of this randomized multi-site clinical trial is to determine whether intensive therapy consisting of cholesterol-lowering statin drugs plus apheresis to cleanse the blood of low-density lipoprotein LDL cholesterol is more effective than statin therapy alone in reducing plaque volume in heart arteries of patients who have already suffered an acute coronary syndrome ACS The study will also investigate whether this intensive approach can help increase the presence of endothelial progenitor cells EPC stem cells that have been shown to reduce cardiovascular CV events in ACS patients This study has II phases and FDA approval for phase II has been received
Detailed Description:
Using statins to lower blood cholesterol and specifically LDL is well established as a long-term strategy to reduce CVs and even death But the most intensive pharmacologic lipid-lowering therapy with statins though proven superior to standard dose regimens is still associated with an unacceptably high rate of recurrent CV events early after an ACS This study hypothesizes that for ACS patients undergoing percutaneous coronary intervention PCI intensive lipid-lowering therapy consisting of statins and LDL-apheresis ILLT will significantly reduce the total coronary atheroma volume of vulnerable plaque and augment mobilization of peripherally circulating EPC colony forming units compared to guideline statin monotherapy SMT ILLT will lead to fewer CV events for these patients
Patients presenting at two VA sites with ACS will be screened and consented before undergoing uncomplicated PCI balloons or stents and intravascular ultrasound with virtual histology IVUS-VH They will then be randomized into the ILLT arm or SMT arm of the study The ILLT group will receive one treatment of LDL-apheresis plus a daily oral 80mg dose of Atorvastatin the SMT group will only get the Atorvastatin Patients will again undergo IVUS-VH 12 weeks after enrollment to measure atheroma volume EPC level will also be checked
The four-year duration of the study includes 24 months of accrual six months of follow-up and 12 months of study closure and data analysis A two-sample t-test of mean difference with 90 power and 065 Cohens D effect size provides a total sample size estimate of 102 Counting 20 drop-out rate the sample size increases to 128
The recent FDA recommendations regarding the design of the study has been included in the revised study protocol
1 The first stage will enroll 30 patients with a 21 randomization favoring LDL-apheresis the safety data will be submitted to the FDA
2 The enrollment of the second stage of the study will be contingent to the recommendations of the FDA
Patients presenting at two VA sites with ACS will be screened and consented before undergoing uncomplicated PCI balloons or stents and intravascular ultrasound with virtual histology IVUS-VH They will then be randomized into the ILLT arm or SMT arm of the study The ILLT group will receive one treatment of LDL-apheresis plus a daily oral 80mg dose of Atorvastatin the SMT group will only get the Atorvastatin Patients will again undergo IVUS-VH 12 weeks after enrollment to measure atheroma volume EPC level will also be checked
The four-year duration of the study includes 24 months of accrual six months of follow-up and 12 months of study closure and data analysis A two-sample t-test of mean difference with 90 power and 065 Cohens D effect size provides a total sample size estimate of 102 Counting 20 drop-out rate the sample size increases to 128
The recent FDA recommendations regarding the design of the study has been included in the revised study protocol
1 The first stage will enroll 30 patients with a 21 randomization favoring LDL-apheresis the safety data will be submitted to the FDA
2 The enrollment of the second stage of the study will be contingent to the recommendations of the FDA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None