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PCSK9 Inhibitor

Alirocumab for Heart Transplant Rejection

Phase 2
Waitlist Available
Led By William F Fearon, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Heart Transplant recipient
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and one year
Awards & highlights

Study Summary

This trial tests whether the drug alirocumab is safe and effective in preventing heart transplant rejection.

Who is the study for?
This trial is for individuals who have recently received a heart transplant. Participants must not have impaired liver function to be eligible.Check my eligibility
What is being tested?
The study tests the safety and effect of alirocumab, a PCSK9 inhibitor, on preventing blood vessel disease in the new heart compared to a placebo (inactive substance).See study design
What are the potential side effects?
Possible side effects of alirocumab include itching, swelling or pain at injection site, flu-like symptoms, nausea, and rarely more serious reactions like allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have received a heart transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in volume of plaque at 1 year post study drug start post heart transplant
Secondary outcome measures
Change in LDL-C
Change in apolipoprotein B
Change in lipoprotein (a)
+1 more

Side effects data

From 2018 Phase 4 trial • 20 Patients • NCT02938949
20%
admission for heart failure
10%
stroke
10%
admission for unstable angina
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alirocumab
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: alirocumabExperimental Treatment1 Intervention
alirocumab 150mg subcutaneous every other week for one year following start of study drug
Group II: placeboPlacebo Group1 Intervention
placebo to match alirocumab every other week for one year following start of study drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
alirocumab
2012
Completed Phase 4
~500

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,390 Previous Clinical Trials
17,340,607 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,835 Previous Clinical Trials
47,310,522 Total Patients Enrolled
William F Fearon, MDPrincipal InvestigatorStanford University
3 Previous Clinical Trials
4,187 Total Patients Enrolled

Media Library

Alirocumab (PCSK9 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03537742 — Phase 2
Vasculopathy Research Study Groups: alirocumab, placebo
Vasculopathy Clinical Trial 2023: Alirocumab Highlights & Side Effects. Trial Name: NCT03537742 — Phase 2
Alirocumab (PCSK9 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03537742 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the biggest number of enrollees that this trial can have and still be considered successful?

"Unfortunately, this particular study is not currently enrolling patients. The last update on the status of the trial was posted on May 22nd, 2022. However, there are 114 other trials related to vasculopathy and 10 studies involving alirocumab that are still admitting participants."

Answered by AI

Can patients currently enroll in this research project?

"Unfortunately, this study is no longer looking for new patients to enroll. Although, it's worth noting that there are 114 other clinical trials still recruiting patients with vasculopathy and 10 more specifically testing alirocumab."

Answered by AI

What are the conditions that alirocumab is most effective in treating?

"Alirocumab has shown efficacy in treating myocardial infarction, hypercholesterolemia, and unstable angina pectoris."

Answered by AI

Are there any dangers associated with alirocumab that patients should be made aware of?

"Alirocumab has received a score of 2 for safety. Phase 2 trials have yielded some data supporting alirocumab's safety, but there is currently no information regarding the efficacy of this medication."

Answered by AI

Is this the first time that alirocumab has been looked at in a scientific setting?

"Currently, there are 10 live clinical trials investigating alirocumab. 1 of those is in Phase 3. While the many trials for alirocumab are based in Chicago, Illinois, there are 12 locations running studies for this treatment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PCSK9 Inhibition After Heart Transplantation
William Fearon 2019. "PCSK9 Inhibition After Heart Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03537742.
~17 spots leftby Feb 2025
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