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

Minneapolis Heart Institute Foundation

Status and phase: Terminated; Phase 4

Conditions: Saphenous Vein Graft Atherosclerosis

Treatments: Drug: Alirocumab 150 MG/ML subcutaneous injection; Drug: Matching Placebo subcutaneous injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03542110

ASAP-SVG, QR#32711/1

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or greater.
2. Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
3. Undergoing clinically-indicated coronary and SVG angiography.
4. Have at least one target saphenous vein graft with an intermediate SVG lesion (defined as a lesion with 30-60% angiographic diameter stenosis) amenable to examination with IVUS. The SVG should have no thrombus or ulceration and should not be considered responsible for the patient's clinical presentation and referral for angiography.
5. Receiving optimal statin therapy defined as use of a high intensity statin (atorvastatin 40-80 mg daily or rosuvastatin 20-40 mg daily), any statin therapy with achieved LDL-C level <70mg/dL, or maximally-tolerated statin dose for patients who are statin intolerant statin.

Exclusion criteria

1. Positive pregnancy test or breast-feeding.
2. Coexisting conditions that limit life expectancy to less than 18 months or that could affect a patient's compliance with the protocol.
3. Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2.
4. Severe peripheral arterial disease limiting vascular access.
5. History of allergic reaction to iodine-based contrast agents that cannot be premedicated.
6. Known hypersensitivity to alirocumab.
7. Any prior use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor therapy.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

Alirocumab 150 MG/ML subcutaneous injection

Active Comparator group

Description:

Alirocumab 150 mg subcutaneously every 2 weeks

Treatment:

Drug: Alirocumab 150 MG/ML subcutaneous injection

Matching Placebo subcutaneous injection

Placebo Comparator group

Description:

Matching placebo subcutaneously every 2 weeks

Treatment:

Drug: Matching Placebo subcutaneous injection