Cardiac Allograft Vasculopathy Inhibition with Alirocumab

NCT ID: NCT03537742

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2025-08-28

Brief Summary

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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

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Conditions

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Vasculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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alirocumab

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

Group Type EXPERIMENTAL

alirocumab

Intervention Type BIOLOGICAL

alirocumab 150mg Subcutaneous

placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

placebo to match alirocumab

Interventions

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alirocumab

alirocumab 150mg Subcutaneous

Intervention Type BIOLOGICAL

placebo

placebo to match alirocumab

Intervention Type BIOLOGICAL

Other Intervention Names

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Praluent

Eligibility Criteria

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Inclusion Criteria

* Heart Transplant recipient

Exclusion Criteria

* impaired liver function
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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William Fearon

Professor, Cardiovascular Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William F Fearon, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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4R33HL139929

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-45975

Identifier Type: -

Identifier Source: org_study_id

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