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PCSK9 Inhibition After Heart Transplantation

Primary Purpose

Vasculopathy

Status

Enrolling by invitation

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

alirocumab

placebo

About this trial

This is an interventional treatment trial for Vasculopathy focused on measuring Heart Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Heart Transplant recipient

Exclusion Criteria:

impaired liver function

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

alirocumab

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in volume of plaque at 1 year post study drug start post heart transplant

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

Change in LDL-C

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

Change in lipoprotein (a)

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

Change in apolipoprotein B

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

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

Full Information

NCT ID

NCT03537742

First Posted

May 15, 2018

Last Updated

May 22, 2022

Sponsor

Stanford University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT03537742

Brief Title

PCSK9 Inhibition After Heart Transplantation

Official Title

PCSK9 Inhibition After Heart Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

May 13, 2019 (Actual)

Primary Completion Date

February 28, 2025 (Anticipated)

Study Completion Date

February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vasculopathy

Keywords

Heart Transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

alirocumab

Arm Type

Experimental

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

alirocumab

Other Intervention Name(s)

Praluent

Intervention Description

alirocumab 150mg Subcutaneous

Intervention Type

Biological

Intervention Name(s)

placebo

Intervention Description

placebo to match alirocumab

Primary Outcome Measure Information:

Title

Change in volume of plaque at 1 year post study drug start post heart transplant

Description

Time Frame

Baseline and one year

Secondary Outcome Measure Information:

Title

Change in LDL-C

Description

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

Time Frame

Baseline, 3, 6 and 12 months

Title

Change in lipoprotein (a)

Description

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

Time Frame

Baseline, 3, 6 and 12

Title

Change in apolipoprotein B

Description

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

Time Frame

Baseline, 3, 6 and 12

Title

Percent change in coronary vessel size by fractional flow reserve

Description

Time Frame

baseline and one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Heart Transplant recipient Exclusion Criteria: impaired liver function

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William F Fearon, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Learn more about this trial

PCSK9 Inhibition After Heart Transplantation

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