PCSK9 Inhibition After Heart Transplantation

Vasculopathy Clinical Trial

Official title:

PCSK9 Inhibition After Heart Transplantation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03537742
• Other study ID #: IRB-45975
• Secondary ID: R61HL139929-01A1
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: May 13, 2019
• Est. completion date: February 28, 2025

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Heart Transplant recipient

Exclusion Criteria:

• impaired liver function

Related Conditions & MeSH terms

• Vascular Diseases
• Vasculopathy

Intervention

Biological:
• alirocumab
alirocumab 150mg Subcutaneous
• placebo
placebo to match alirocumab

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and one year
Secondary	Change in LDL-C	measure differences in LDL-C lipid particle values between the two arms at baseline, 3, 6 and 12 months	Baseline, 3, 6 and 12 months
Secondary	Change in lipoprotein (a)	measure differences lipid particle lipoprotein (a) values between the two arms at Baseline, 3, 6 and 12 months	Baseline, 3, 6 and 12
Secondary	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	Baseline, 3, 6 and 12
Secondary	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	baseline and one year