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The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial

NCT03542110 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2021-09-16

No results posted yet for this study

Summary

This is a phase IV, multi-center, double-blind, randomized, placebo- controlled study evaluating the effect of alirocumab on SVG atherosclerotic disease burden, as assessed by IVUS at baseline and following 78 weeks of treatment in subjects with at least one intermediate SVG lesion receiving optimal statin therapy. Subjects will be randomized 1:1 into 2 treatment groups: alirocumab 150 mg subcutaneously every 2 weeks or placebo subcutaneously every 2 weeks.

Conditions

  • Saphenous Vein Graft Atherosclerosis

Interventions

DRUG

Alirocumab 150 MG/ML subcutaneous injection

Single-dose, pre-filled, disposable, subcutaneous injection pen

DRUG

Matching Placebo subcutaneous injection

Single-dose, pre-filled, disposable, subcutaneous injection pen

Sponsors & Collaborators

Principal Investigators

  • Emmanouil S Brilakis, MD, PhD · Minneapolis Heart Institute and Foundation/ Abbott Northwestern Hospital-Allina Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-04
Primary Completion
2020-06-30
Completion
2020-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03542110 on ClinicalTrials.gov