31 and older, any sex, with Acute Coronary Artery Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in the Total Atheroma Volume From Baseline to 12 WeeksPrimary· 12 weeks
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 90-day follow-up).
Group
Value
95% CI
Intensive LDL-lowering Therapy (ILLT)
-7.63
± 23.78
Standard Statin Monotherapy (SMT)
-3.10
± 17.74
Change in % Necrotic Core Component of AtheromaSecondary· 12 weeks
The %NC component of atheroma were obtained via IVUS-VH at 2 time points (baseline during index PCI and 90-day follow-up).
Group
Value
95% CI
Intensive LDL-lowering Therapy (ILLT)
0.44
± 6.81
Standard Statin Monotherapy (SMT)
0.94
± 9.89
Endothelial Progenitor Cell Colony Forming Units/ml of Peripheral Blood Across TimeSecondary· 12 weeks
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, 30-day follow-up, and 90-day follow-up).
baseline pre-PCI
Group
Value
95% CI
Intensive LDL-lowering Therapy (ILLT)
11.85
± 9.24
Standard Statin Monotherapy (SMT)
11.99
± 11.37
baseline post-PCI
Group
Value
95% CI
Intensive LDL-lowering Therapy (ILLT)
15.30
± 10.96
Standard Statin Monotherapy (SMT)
17.89
± 16.91
30-day
Group
Value
95% CI
Intensive LDL-lowering Therapy (ILLT)
21.60
± 14.78
Standard Statin Monotherapy (SMT)
20.40
± 17.87
90-day
Group
Value
95% CI
Intensive LDL-lowering Therapy (ILLT)
16.32
± 13.29
Standard Statin Monotherapy (SMT)
15.06
± 14.33
Major Adverse CV EventsSecondary· 6 months
The number of patients who experienced major adverse cardiovascular endpoints (MACE) including death, myocardial infarction, coronary revascularization, and stroke during the follow-up periods.
Group
Value
95% CI
Intensive LDL-lowering Therapy (ILLT)
5
Standard Statin Monotherapy (SMT)
2
Adverse events — posted to ClinicalTrials.gov
Time frame: AE/SAE/UADE were monitored at the study sites throughout the whole period of the study at each clinic visit and telephone contact, beginning as soon as a study participant signs the Informed Consent and continuing through end-of-study for each participant. Most participants were followed for around 6 months for AE/SAE/UADE..
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 30 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02347098.