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NCT02959047 · ClinicalTrials.gov registry record · Phase 4
A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease
A Phase 4 study, sponsored by University of Virginia.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT02959047: Completed Phase 4 study, sponsored by University of Virginia.
NCT02959047 is a Phase 4 study that has completed, run by University of Virginia. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02959047, a Phase 4 study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
Peripheral arterial disease (PAD) is characterized by lower limb arterial obstruction due to atherosclerosis. Magnetic resonance imaging (MRI) methods can accurately quantify atherosclerotic plaque in the superficial femoral artery (SFA) in patients with PAD. Such techniques have demonstrated plaque regression with statin therapy over 1 year. Alirocumab is a PCSK9 inhibitor that effectively reduces LDL cholesterol up to 70% in patients on statins or intolerant to statins. The investigators hypothesize that effective low density lipoprotein (LDL) lowering with Alirocumab 150m subcutaneously (SQ) every 2 weeks will regress atherosclerotic plaque in the SFA in patients with PAD over one year compared to placebo. 54 patients with mild-moderate PAD (ankle brachial index or ABI 0.4-0.9) will be randomized to alirocumab 150 mg SQ every 2 weeks or matching placebo at the University of Virginia (UVA) (n=34) and Northwestern (n=20). The primary endpoint is change in atherosclerotic plaque volume in the superficial femoral artery over the 1 year treatment period. Secondary endpoints include changes in peak calf muscle perfusion after thigh cuff occlusion/hyperemia, 6-minute walk distance, and blood biomarkers (LDL cholesterol, fibrinogen, high sensitivity c-reactive protein (hs-CRP), and lipoprotein(a).
Primary Outcome
Measured by black blood MRI, expressed in cm3
Interventions
- DRUG Matching placebo
- DRUG Alirocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-07-17 |
| Est. Completion | 2023-05-08 |
| Phase | Phase 4 |
What the finished NCT02959047 record still lists
NCT02959047 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Matching placebo is the first listed.
NCT02959047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02959047 about?
NCT02959047 is a clinical study titled "A Trial of Alirocumab and Plaque Regression in Peripheral Arterial Disease". Peripheral arterial disease (PAD) is characterized by lower limb arterial obstruction due to atherosclerosis. Magnetic resonance imaging (MRI) methods can accurately quantify atherosclerotic plaque in the superficial femoral artery (SFA) in patients with PAD. Such techniques have demonstrated plaque...
What is the current status of trial NCT02959047?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2017-07-17. Estimated completion is 2023-05-08.
What interventions are being tested in trial NCT02959047?
The interventions under investigation include: Matching placebo (DRUG), Alirocumab (DRUG).
Who is sponsoring clinical trial NCT02959047?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02959047's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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