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

Conditions

• Saphenous Vein Graft Atherosclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Alirocumab 150 MG/ML subcutaneous injection — DRUG
  Single-dose, pre-filled, disposable, subcutaneous injection pen
• Matching Placebo subcutaneous injection — DRUG
  Single-dose, pre-filled, disposable, subcutaneous injection pen

Study Details

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.

Key Dates

Start date

Aug 4, 2018

Status verified

Sep 2021

Primary completion

Jun 30, 2020

Completion

Jul 31, 2020

Study Design

Enrollment

46 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Alirocumab 150 MG/ML subcutaneous injection
  Alirocumab 150 mg subcutaneously every 2 weeks
• Placebo Comparator: Matching Placebo subcutaneous injection
  Matching placebo subcutaneously every 2 weeks

Primary Outcome Measure

Nominal change in intermediate SVG lesion percent atheroma volume (PAV) from baseline to 78 weeks post randomization, as assessed by intravascular ultrasonography (IVUS). [ Time Frame: 78 weeks ]

Locations (4)

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