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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 is a Phase 4 study that has completed, run by University of Virginia. The registered enrollment target is 40 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02959047
The ClinicalTrials.gov registry entry for NCT02959047 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Matching placebo is the first listed.
NCT02959047 reports 0 study locations.
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.
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