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NCT03537742 · ClinicalTrials.gov registry record · Phase 2

Cardiac Allograft Vasculopathy Inhibition With Alirocumab

A Phase 2 study, sponsored by Stanford University.

Completed
Registry status
Phase 2
Development phase
114
Enrollment target

NCT03537742: Completed Phase 2 study, sponsored by Stanford University.

NCT03537742 is a Phase 2 study that has completed, run by Stanford University. The registered enrollment target is 114 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT03537742, a Phase 2 study, has completed, sponsored by Stanford University.

COMPLETED
Registry status
Phase 2
Development phase
114 participants
Enrollment target

Study Summary

The focus of this study is to test the safety and efficacy of the PCSK9 inhibitor, alirocumab when administered early after heart transplantation (HT).The main objective of this project is to test the safety and impact on cardiac allograft vasculopathy (CAV) of alirocumab when given early after HT.

Primary Outcome

Coronary artery plaque volume (mm³) was assessed using intravascular ultrasound (IVUS) during coronary angiography. Measurements were obtained at baseline (prior to study drug randomization) and at 1 year following treatment. The outcome measure represents the change in plaque volume from baseline to 1 year.

Interventions

  • BIOLOGICAL placebo
  • BIOLOGICAL alirocumab

Trial Details

FieldValue
Enrollment Target 114 participants
Start Date 2019-05-13
Est. Completion 2025-07-11
Phase Phase 2
Stanford University

1,744 total trials

What the finished NCT03537742 record still lists

NCT03537742 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT03537742 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03537742 about?

NCT03537742 is a clinical study titled "Cardiac Allograft Vasculopathy Inhibition With Alirocumab". The focus of this study is to test the safety and efficacy of the PCSK9 inhibitor, alirocumab when administered early after heart transplantation (HT).The main objective of this project is to test the safety and impact on cardiac allograft vasculopathy (CAV) of alirocumab when given early after HT.

What is the current status of trial NCT03537742?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2019-05-13. Estimated completion is 2025-07-11.

What interventions are being tested in trial NCT03537742?

The interventions under investigation include: placebo (BIOLOGICAL), alirocumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT03537742?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03537742's enrollment target sits among peer trials

114 627th of 2000 higher than 1,370 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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Source: ClinicalTrials.gov NCT03537742, the US trial registry maintained by the National Library of Medicine. NCT03537742 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.