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PCSK9 Inhibition After Heart Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537742
Recruitment Status : Enrolling by invitation
First Posted : May 25, 2018
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
William Fearon, Stanford University

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
Vasculopathy Biological: alirocumab Biological: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Alirocumab

Arm Intervention/treatment
Experimental: alirocumab
alirocumab 150mg subcutaneous every other week for one year following transplant
Biological: alirocumab
alirocumab 150mg Subcutaneous
Other Name: Praluent

Placebo Comparator: placebo
placebo to match alirocumab every other week for one year following transplant
Biological: placebo
placebo to match alirocumab




Primary Outcome Measures :
  1. Change in volume of plaque at 1 year post heart transplant [ Time Frame: 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 transplant


Secondary Outcome Measures :
  1. Change in LDL-C [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heart Transplant recipient

Exclusion Criteria:

  • impaired liver function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537742


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: William F Fearon, MD Stanford University
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Responsible Party: William Fearon, Professor, Cardiovascular Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03537742    
Other Study ID Numbers: IRB-45975
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020

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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, Stanford University:
Heart Transplant
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases