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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 : March 17, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
William Fearon, Stanford University

Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE May 25, 2018
Last Update Posted Date March 17, 2021
Actual Study Start Date  ICMJE May 13, 2019
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2021)
Change in volume of plaque at 1 year post study drug start 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 study drug start post transplant
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PCSK9 Inhibition After Heart Transplantation
Official Title  ICMJE PCSK9 Inhibition After Heart Transplantation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Vasculopathy
Intervention  ICMJE
  • Biological: alirocumab
    alirocumab 150mg Subcutaneous
    Other Name: Praluent
  • Biological: placebo
    placebo to match alirocumab
Study Arms  ICMJE
  • Experimental: alirocumab
    alirocumab 150mg subcutaneous every other week for one year following start of study drug
    Intervention: Biological: alirocumab
  • Placebo Comparator: placebo
    placebo to match alirocumab every other week for one year following start of study drug
    Intervention: Biological: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 15, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Heart Transplant recipient

Exclusion Criteria:

  • impaired liver function
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03537742
Other Study ID Numbers  ICMJE IRB-45975
R61HL139929-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William Fearon, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: William F Fearon, MD Stanford University
PRS Account Stanford University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP