CCTA #0002: PREMIER - VA Cooperative Studies Program (CSP)
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VA Cooperative Studies Program (CSP)

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CCTA #0002: PREMIER


Official title: Plaque Regression and Progenitor Cell Mobilization with Intensive Lipid Elimination Regimen (PREMIER)

Data Sharing Statement

What's available?

Pending

Available Documentation

Pending

Dates Data are Available

Pending

Access Criteria

Pending

Study Characteristics

Objectives

  • 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)
  • To investigate whether this intensive approach can help increase the presence of endothelial progenitor cells (EPC), stem cells that have been shown to reduce cardiovascular events in ACS patients

Era of Service

All

Population

Male and female patients at VA Medical Centers who present with ACS and were referred for clinically-indicated, non-emergent coronary angiography and percutaneous coronary intervention (PCI) with intravascular ultrasound with virtual histology (IVUS-VH) of target coronary artery for ACS, and meet additional strict inclusion and exclusion criteria

Study Design

Randomized, single-blinded, clinical trial

Intervention 

  • Experimental Intensive LDL-lowering Therapy (ILLT) group: LDL-apheresis followed by atorvastatin 
  • Control standard statin monotherapy (SMT) group: Atorvastatin without LDL-apheresis 

Time Period

March 2015 - September 2018 (estimated)

Setting

National

N

128 (estimated enrollment for PREMIER, Phase II)

Response Rate

N/A

Recruitment Method

Potential participants were screened and consented within the first 24 hours of admission for ACS at 4 VA medical centers

Compensation

  • $50 for participating in the study
  • $25 for each follow-up visit

Data Collected

Primary outcomes

  • Change in the total atheroma volume within at least 20mm of the target coronary artery from baseline to 12 weeks

Secondary outcomes 

  • Percent necrotic core component of atheroma
  • Endothelial progenitor cell colony forming units/ml of peripheral blood
  • Major adverse cardiovascular events during the follow-up periods

Other assessments

  • Demographics
  • Complete history and physical, including blood pressure, heart rate, coronary artery disease (CAD) history, 12-lead electrocardiogram (ECG), full blood test (lipid profile with VLDL, CBC, BMP & LFT, CK & CKMB & Troponins), and adjunctive pharmacotherapy data

Data Collection Methods 

Case report forms at each site visit entered into an electronic data capture system

Funding Source

VA Cooperative Studies Program (CSP), Cooperative Clinical Trial Award (CCTA) Program

Contact

Daniel.Lippe@va.gov

Selected Publication

Banerjee S, Abu Fadel M, Sarode R, Terada L, Moritz T, Luo P, et al. Place regression and progenitor cell mobilization with intensive lipid elimination regimen (PREMIER) trial design. J Clin Apher. 2014 Apr;29(2):97-106.

More Information

Study ClinicalTrials.gov site
ClinicalTrials.gov Identifier: NCT02347098