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Monoclonal Antibodies

Alirocumab 150 MG/ML subcutaneous injection for Coronary artery disease (ASAP-SVG Trial)

Phase 4
Waitlist Available
Research Sponsored by Minneapolis Heart Institute Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization to 80 weeks
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

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.

Eligible Conditions
  • Coronary artery disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization to 80 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to 80 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Nominal change in intermediate SVG lesion percent atheroma volume (PAV) from baseline to 78 weeks post randomization, as assessed by intravascular ultrasonography (IVUS).
Secondary study objectives
Angiographic failure of target SVG lesion from baseline to 78 weeks.
Incidence of target SVG failure and major adverse cardiac events.
Nominal change in TAV and normalized TAV of an intermediate SVG lesion from baseline to 78 weeks

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Alirocumab 150 MG/ML subcutaneous injectionActive Control1 Intervention
Alirocumab 150 mg subcutaneously every 2 weeks
Group II: Matching Placebo subcutaneous injectionPlacebo Group1 Intervention
Matching placebo subcutaneously every 2 weeks

Find a Location

Who is running the clinical trial?

Minneapolis Heart Institute FoundationLead Sponsor
30 Previous Clinical Trials
15,614 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
386,456 Total Patients Enrolled
Emmanouil S Brilakis, MD, PhDStudy ChairMinneapolis Heart Institute and Foundation/ Abbott Northwestern Hospital-Allina Health
16 Previous Clinical Trials
3,011 Total Patients Enrolled
~6 spots leftby Nov 2025
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