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NCT01004406 · ClinicalTrials.gov registry record · Phase 3
Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER), Phase I
A Phase 3 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 59
- Enrollment target
NCT01004406: Completed Phase 3 study, sponsored by VA Office of Research and Development.
NCT01004406 is a Phase 3 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 59 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01004406, a Phase 3 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 59 participants
- Enrollment target
Study 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 II phases and FDA approval for phase II has been received.
Interventions
- DEVICE intensive LDL-lowering therapy
- DRUG standard statin monotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01004406
The ClinicalTrials.gov registry entry for NCT01004406 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which intensive LDL-lowering therapy is the first listed.
NCT01004406 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01004406 about?
NCT01004406 is a clinical study titled "Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER), Phase I". 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 ...
What is the current status of trial NCT01004406?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 59 participants. The study started on 2011-09. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01004406?
The interventions under investigation include: intensive LDL-lowering therapy (DEVICE), standard statin monotherapy (DRUG).
Who is sponsoring clinical trial NCT01004406?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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