Clinical trial NCT03542110: The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial
Official title: Effect of Alirocumab on Saphenous Vein Graft Atherosclerosis: The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Saphenous Vein Graft Atherosclerosis
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2018-05-31
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Nominal change in intermediate SVG lesion percent atheroma volume (PAV) from baseline to 78 weeks post randomization, as assessed by intravascular ultrasonography (IVUS).
timeFrame: 78 weeks
Secondary outcomes:
measure: Nominal change in TAV and normalized TAV of an intermediate SVG lesion from baseline to 78 weeks
timeFrame: 78 weeks
measure: Angiographic failure of target SVG lesion from baseline to 78 weeks.
timeFrame: 78 weeks
measure: Incidence of target SVG failure and major adverse cardiac events.
timeFrame: Randomization to 80 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: Atlanta
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute/ Abbott North Western Hospital-Allina Health
state: Minnesota
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
Study officials:
affiliation: Minneapolis Heart Institute and Foundation/ Abbott Northwestern Hospital-Allina Health
name: Emmanouil S Brilakis, MD, PhD
role: STUDY_CHAIR
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