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

September 15, 2021 updated by: Minneapolis Heart Institute Foundation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • San Francisco VA Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30033
        • Atlanta VA Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute/ Abbott North Western Hospital-Allina Health
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Alirocumab 150 MG/ML subcutaneous injection
Alirocumab 150 mg subcutaneously every 2 weeks
Drug: Alirocumab 150 MG/ML subcutaneous injection
Single-dose, pre-filled, disposable, subcutaneous injection pen
Other Names:
  • Praluent, Study Drug
PLACEBO_COMPARATOR: Matching Placebo subcutaneous injection
Matching placebo subcutaneously every 2 weeks
Drug: Matching Placebo subcutaneous injection
Single-dose, pre-filled, disposable, subcutaneous injection pen
Other Names:
  • Placebo, Study Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
To evaluate the effect of alirocumab on the change in burden of saphenous vein graft (SVG) atherosclerosis as measured by percent atheroma volume (PAV) in patients with intermediate SVG lesions who are undergoing clinically-indicated coronary angiography and are receiving optimal statin therapy.
78 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nominal change in TAV and normalized TAV of an intermediate SVG lesion from baseline to 78 weeks
Time Frame: 78 weeks
evaluate the effect of alirocumab on the change in total and normalized total atheroma volume (TAV) of an intermediate SVG lesion
78 weeks
Angiographic failure of target SVG lesion from baseline to 78 weeks.
Time Frame: 78 weeks
To evaluate the effect of alirocumab on the incidence of angiographic failure of an intermediate target SVG lesion.
78 weeks
Incidence of target SVG failure and major adverse cardiac events.
Time Frame: Randomization to 80 weeks
To evaluate the effect of alirocumab on the incidence of target SVG failure (defined as the composite of death, myocardial infarction, and target lesion revascularization) and the incidence of major adverse cardiac events (MACE, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during follow-up.
Randomization to 80 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minneapolis Heart Institute Foundation

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Study Chair: Emmanouil S Brilakis, MD, PhD, Minneapolis Heart Institute and Foundation/ Abbott Northwestern Hospital-Allina Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 4, 2018

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ACTUAL)

July 31, 2020

Study Registration Dates

First Submitted

May 18, 2018

First Submitted That Met QC Criteria

May 18, 2018

First Posted (ACTUAL)

May 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASAP-SVG, QR#32711/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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