CCTA #0002: PREMIER - 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), Phase II (PREMIER)

Investigator Access

What's Available

Check with the study contact and publications for information on a public dataset, data archive, data enclave, or website where data might be available

Available Documentation

Dates Data are Available


Check with the study contact and publications for information on a public dataset, data archive, data enclave, or website where data might be available

Access Criteria

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 31 years and older 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, parallel assignment, single-blinded, clinical trial

Interventions 

  • Experimental arm: Intensive LDL-lowering Therapy (ILLT); LDL-apheresis followed by standard statin monotherapy
  • Active comparator: Standard Statin Monotherapy (SMT); standard statin monotherapy

Time Period

March 2015 - September 2019

Setting

National

N

270 enrolled, 129 randomized

Response Rate

Unconfirmed

Recruitment Method

Potential participants were screened and consented within the first 24 hours of admission for ACS at 4 Veteran Affairs Medical Centers. Eligible participants were subsequently asked to sign an IRB-approved informed consent form.

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 were completed at each visit by site coordinators who entered data into an electronic data capture system.

Funding Sources

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

Investigators

Subhash Banerjee, MD

Contact

Daniel.Lippe@va.gov

Selected Publication

Banerjee S, Abu Fadel M, Sarode R, Terada L, Moritz T, Luo P, Hastings J, Brilakis ES, Reda D. 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
  • Dimensions for VA summary (Requires an account to access outside the VA network. Dimensions for VA is a database that connects publications, grants, patents, clinical trials, and policy documents)