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



Status:Enrolling by invitation
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:11/22/2018
Start Date:August 4, 2018
End Date:March 2021

Use our guide to learn which trials are right for you!

Effect of Alirocumab on Saphenous Vein Graft Atherosclerosis: The Alirocumab for Stopping Atherosclerosis Progression in Saphenous Vein Grafts (ASAP-SVG) Pilot Trial

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.


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.
We found this trial at
4
sites
303 Parkway Drive Northeast
Atlanta, Georgia 30033
Principal Investigator: Kreton Mavromatis, MD
Phone: 404-321-6111
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
4500 S. Lancaster Rd.
Dallas, Texas 75216
800-849-3597
Principal Investigator: Subhash Banerjee, MD
Phone: 214-857-2206
Dallas VA Medical Center VA North Texas Health Care System (VANTHCS) is a progressive health...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Minneapolis, Minnesota 55407
Principal Investigator: Emmanouil S Brilakis, MD, PhD
Phone: 612-863-6066
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
San Francisco, California 94121
Principal Investigator: Kendrick Shunk, MD, PhD
Phone: 415-221-4810
?
mi
from
San Francisco, CA
Click here to add this to my saved trials