Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER), Phase II

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 two phases and FDA approval for phase II has been received and all information has been updated to reflect PREMIER Phase II.

Timeline

Start

2015-03-30

Primary completion

2018-02-28

Completion

2019-09-30

Publications

• Kole A, Hua F, Wei Y, Carlson K, Hayenga HN, Banerjee S. Analysis of Plaque Characteristics by Virtual Histology-Intravascular Ultrasound in Short-Term Follow-Up Post-Acute Coronary Syndrome and Association With Lipid-Lowering Therapy: Insights From the PREMIER Trial. J Am Heart Assoc. 2023 May 16;12(10):e028873. doi: 10.1161/JAHA.122.028873. Epub 2023 May 9. No abstract available.
• Banerjee S, Luo P, Reda DJ, Latif F, Hastings JL, Armstrong EJ, Bagai J, Abu-Fadel M, Baskar A, Kamath P, Lippe D, Wei Y, Scrymgeour A, Gleason TC, Brilakis ES. Plaque Regression and Endothelial Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER). Circ Cardiovasc Interv. 2020 Aug;13(8):e008933. doi: 10.1161/CIRCINTERVENTIONS.119.008933. Epub 2020 Aug 14.

Drugs

Indications