Phase 3
N=129
Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER), Phase II
Acute Coronary Artery Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02347098 ↗Enrolled (actual)
129
Serious AEs
43.4%
Results posted
Jul 2019
Primary outcome: Primary: Change in the Total Atheroma Volume From Baseline to 12 Weeks — -7.63; -3.10 mm^3 — p=0.2533
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- intensive LDL-lowering therapy (Device); standard statin monotherapy (Drug)
- Age
- Adult, Older Adult · 31+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Total Atheroma Volume From Baseline to 12 Weeks |
-7.63; -3.10 | 0.2533 |
| SECONDARY Change in % Necrotic Core Component of Atheroma |
0.44; 0.94 | 0.7790 |
| SECONDARY Endothelial Progenitor Cell Colony Forming Units/ml of Peripheral Blood Across Time |
11.85; 11.99; 15.30; 17.89; 21.60; 20.40 | 0.4549 |
| SECONDARY Major Adverse CV Events |
5; 2 | 0.2663 |
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.
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide informed consent (including HIPAA)
- Age >30 years
- Presenting with acute coronary syndrome (ACS), manifested as unstable angina or non-ST-elevation myocardial infarction
- Referred for clinically-indicated, non-emergent (the procedure is not required to be performed within 3 hours after patient presentation) coronary angiography and PCI with Intravascular Ultrasound with Virtual Histology (IVUS-VH) of target coronary artery for ACS
- Successful placement of two large bore IV cannulas in bilateral upper extremities
- Fasting (12 hrs.) LDL 70mg/dl while on less than or equal to 80mg Atorvastatin or equivalent dose of other statin, performed at time of admission or prior to PCI.
Exclusion Criteria
- Known allergy to aspirin, clopidogrel, statins, or iodinated contrast
- Positive pregnancy test, planning to become pregnant, or breast-feeding
- Coexisting conditions that limit life expectancy to less than six months or affect patient compliance
- Uncontrolled fasting (12 hrs.) triglyceride levels ( 500mg/dl)
- Already participating in an investigational device or drug study
- History of heparin induced thrombocytopenia (HIT)
- Persons with estimated glomerular filtration rate (eGFR) of less than 45 ml/min
- ST-elevation myocardial infarction at admission
- Abnormal liver function test (LFT) at time of admission or prior to PCI with abnormal LFT defined as any liver transaminases (ALT or AST) 3 times the upper limit of the normal laboratory reference
- Pre-PCI or post-PCI left ventricular ejection fraction 5 cm or requiring medical treatment; arteriovenous (AV) fistula; pseudo aneurysm requiring treatment; retroperitoneal bleeding), or PCI with any of the procedural complications (abrupt vessel closure; no-reflow phenomenon; new angiographic thrombus; new major dissection with reduced flow; catheter-related thrombus), or PCI requiring further medical treatments (urgent coronary artery bypass graft (CABG); endotracheal intubation; unplanned in-aortic balloon pump; left ventricular assist device (LVAD); covered stent; unplanned temporary pacemaker wire; administration of inotropes; cardiopulmonary resuscitation (CPR)) , or PCI resulting in clinical events (death; stroke; myocardial infarction; stent thrombosis) during or within 24 hours after the index PCI
- Post-PCI ongoing chest pain
- Post-PCI severe groin pain and hematoma > 5cm in diameter
- Persons whose hemoglobin is less than 9 grams following the index PCI/IVUS procedure, or who experience a drop in hemoglobin of greater than or equal to 2 grams following the procedure
- Not able to comply with study protocol as determined by the investigators
Data sourced from ClinicalTrials.gov (NCT02347098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.