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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
Must not have
Impaired liver function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and one year
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My liver isn't working properly.

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
2,411 Previous Clinical Trials
17,462,819 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,854 Previous Clinical Trials
47,817,752 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
~12 spots leftby Feb 2025
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