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

• Status: Terminated
• Trial end date: 2020-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Minneapolis Heart Institute Foundation
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal

Criteria

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.