Acute Coronary Syndrome Clinical Trial
— PREMIEROfficial title:
Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER)
Verified date | July 2019 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | March 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 31 Years and older |
Eligibility |
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 IVUS-VH of target coronary artery for ACS - Successful placement of two large bore IV cannulas in bilateral upper extremities - Fasting (>= 12 hours) LDL >= 100mg/dl while on <= 80mg Atorvastatin or equivalent dose of other statin, performed at time of admission or 3 months 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 hours) 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) less than 60 ml/min if they are diabetic; persons with eGFR of less than 45 ml/min if they are not diabetic - ST-elevation myocardial infarction at admission - Abnormal liver function test (LFT) at time of admission or 3 month 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 <25% by echo or cardiac catheterization done after admission - Pre-PCI, intra-PCI, or post-PCI hemodynamic instability with hypotension - Pre-PCI, intra-PCI, or post-PCI cardiac arrest - Pre-PCI or post-PCI heart failure with or without pulmonary edema - Intra-PCI or post-PCI sustained ventricular tachycardia - Complicated PCI, defined as PCI with any of the vascular access complications (large hematoma with lump > 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 grafting (CABG); endotracheal intubation; unplanned in-aortic balloon pump; left ventricular assist device (LVAD); covered stent; unplanned temporary pacemaker wire; administration of inotropes; 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 |
Country | Name | City | State |
---|---|---|---|
United States | VA North Texas Health Care System, Dallas | Dallas | Texas |
United States | Oklahoma City VA Medical Center, Oklahoma City, OK | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the Total Atheroma Volume of the Target Coronary Artery From Baseline to 12 Weeks Post-PCI as Assessed Via Intravascular Ultrasound With Virtual Histology (IVUS-VH) | The primary effectiveness outcome measure was the change in the total atheroma volume within a = 20 mm long segment of the target coronary artery from baseline to 12 weeks post-PCI. The measurement was done via IVUS-VH at 2 time points (baseline during index PCI and 12-week follow-up). | baseline and 12-week follow-up | |
Secondary | Change in % Necrotic Core (NC) Component of Atheroma From Baseline to 12 Weeks Post-PCI as Assessed Via IVUS-VH | The %NC component of atheroma were obtained via IVUS-VH at 2 time points (baseline during index PCI and 12-week follow-up). | baseline and 12-week follow-up | |
Secondary | Endothelial Progenitor Cell Colony Forming Units (EPC-CFU) Per Milliliter of Peripheral Blood Across Time | The cell culture assay and quantification of circulating EPC-CFU were performed for patients recruited at the Dallas VA center only. The assay were done at 4 time points (pre-PCI, post-PCI, 4-week follow-up, and 12-week follow-up). | pre-PCI, post-PCI, 4-week follow-up, and 12-week follow-up | |
Secondary | Major Adverse Cardiovascular Events | The number of patients who experienced major adverse cardiovascular endpoints (MACE) including death, myocardial infarction, coronary revascularization, and stroke during the follow-up periods. | 6 months |
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