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NCT03944577 · ClinicalTrials.gov registry record · Phase 2
Impact of Evolocumab in Cardiac Transplant Patients With CAV
A Phase 2 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT03944577: Completed Phase 2 study, sponsored by University of Nebraska.
NCT03944577 is a Phase 2 study that has completed, run by University of Nebraska. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03944577, a Phase 2 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
Coronary allograft vasculopathy (CAV) is diffusely accelerated atherosclerosis of a transplanted heart. Evolocumab (Repatha) is an FDA-approved drug for lowering low density lipoprotein (LDL) in patients who have not received a heart transplant. This drug works as a PCSK9-inhibitor. The primary objective of this study is to measure the impact of PCSK9-inhibitors on serum LDL in heart transplant patients with CAV after 12 weeks compared to baseline.
Primary Outcome
The primary outcome measure for this study was percent change in LDL from baseline after 12 weeks of evolocumab therapy. Serum LDL was measured at baseline and after 12 weeks of evolocumab therapy. This primary endpoint was used in prior phase 2 trials investigating evolocumab in other patient populations. Wilcoxon matched-pairs signed rank test was used for statistical assessment.
Interventions
- DRUG Evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-07-15 |
| Est. Completion | 2023-03-28 |
| Phase | Phase 2 |
What the finished NCT03944577 record still lists
NCT03944577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Evolocumab is the first listed.
NCT03944577 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03944577 about?
NCT03944577 is a clinical study titled "Impact of Evolocumab in Cardiac Transplant Patients With CAV". Coronary allograft vasculopathy (CAV) is diffusely accelerated atherosclerosis of a transplanted heart. Evolocumab (Repatha) is an FDA-approved drug for lowering low density lipoprotein (LDL) in patients who have not received a heart transplant. This drug works as a PCSK9-inhibitor. The primary obje...
What is the current status of trial NCT03944577?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2019-07-15. Estimated completion is 2023-03-28.
What interventions are being tested in trial NCT03944577?
The interventions under investigation include: Evolocumab (DRUG).
Who is sponsoring clinical trial NCT03944577?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03944577's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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