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PCSK9 Inhibition After Heart Transplantation

Sponsor
Stanford University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03537742
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
120
Enrollment
1
Location
2
Arms
69.6
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: alirocumab
  • Biological: placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
PCSK9 Inhibition After Heart Transplantation
Actual Study Start Date :
May 13, 2019
Anticipated Primary Completion Date :
Feb 28, 2025
Anticipated Study Completion Date :
Feb 28, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: alirocumab

alirocumab 150mg subcutaneous every other week for one year following start of study drug

Biological: alirocumab
alirocumab 150mg Subcutaneous
Other Names:
  • Praluent

    		•
    Placebo Comparator: placebo

    placebo to match alirocumab every other week for one year following start of study drug

    Biological: placebo
    placebo to match alirocumab

    Outcome Measures

    Primary Outcome Measures

    1. Change in volume of plaque at 1 year post study drug start post heart transplant [Baseline and one year]

      Measured change in coronary artery plaque volume(MM3), measured by Intravascular Ultrasound at time of coronary arteriogram within 4-8 weeks post transplant( baseline) and one year after study drug start post transplant

    Secondary Outcome Measures

    1. Change in LDL-C [Baseline, 3, 6 and 12 months]

      measure differences in LDL-C lipid particle values between the two arms at baseline, 3, 6 and 12 months

    2. Change in lipoprotein (a) [Baseline, 3, 6 and 12]

      measure differences lipid particle lipoprotein (a) values between the two arms at Baseline, 3, 6 and 12 months

    3. Change in apolipoprotein B [Baseline, 3, 6 and 12]

      measure differences in apolipoprotein B lipid particle apolipoprotein B values between the two arms at baseline, 3, 6 and 12 months

    4. Percent change in coronary vessel size by fractional flow reserve [baseline and one year]

      evaluate the ability of fractional flow reserve (% change in vessel size) to predict clinically meaningful increases in plaque volume one year post-transplant relative to that of plaque volume measured via intravascular ultrasound at baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Heart Transplant recipient
    Exclusion Criteria:
    • impaired liver function

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: William F Fearon, MD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    William Fearon, Professor, Cardiovascular Medicine, Stanford University
    ClinicalTrials.gov Identifier:
    NCT03537742
    Other Study ID Numbers:
    • IRB-45975
    • R61HL139929-01A1
    • R33HL139929
    First Posted:
    May 25, 2018
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by William Fearon, Professor, Cardiovascular Medicine, Stanford University
    Heart Transplant
    Additional relevant MeSH terms:
    Vascular Diseases

    Study Results

    No Results Posted as of May 24, 2022