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Monoclonal Antibodies

Effect of Evolocumab on Coronary Plaque Characteristics (YELLOW III Trial)

Phase 4

Waitlist Available

Led By Annapoorna Kini, MD

Research Sponsored by Annapoorna Kini

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 baseline and 1 year

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a cholesterol-lowering injection in patients with stable coronary artery disease who are already on high-dose statins. The goal is to see if this injection can further reduce plaque buildup in their arteries. Researchers will use various methods to measure changes in the artery plaques over several months. The injection works by lowering cholesterol levels by approximately 60%.

Eligible Conditions

Coronary Artery Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Minimal Fibrous Cap Thickness (FCT)

Change in maxNIRS4mm

Secondary study objectives

Change in Calcification Accumulation

Change in Lipid Length

Change in Lipid Volume Index (LVI)

+6 more

Side effects data

From 2023 Phase 4 trial • 137 Patients • NCT04710368

10%

Chest pain/tightness

Urgent Revascularization

Groin Pain

Shortness of breath

Fatigue

Back/feet pain

Cold/flu-like symptoms

Indigestion

Atrial Fibrillation

Myocardial Infarction

Fever

Corneal abrasion

COVID

Food poisoning

Nose bleed

Papules

Hives

100%

80%

60%

40%

20%

Study treatment Arm

Treatment

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Evolocumab subcutaneously administered 140 mg every 2 weeks for 26 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Evolocumab Injections

2021

Completed Phase 4

~140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Annapoorna KiniLead Sponsor

1 Previous Clinical Trials

87 Total Patients Enrolled

1 Trials studying Coronary Artery Disease

87 Patients Enrolled for Coronary Artery Disease

Annapoorna Kini, MD4.86 ReviewsPrincipal Investigator - Icahn School of Medicine at Mount Sinai

Icahn School of Medicine at Mount Sinai

6 Previous Clinical Trials

5,218 Total Patients Enrolled

5 Trials studying Coronary Artery Disease

523 Patients Enrolled for Coronary Artery Disease

5Patient Review

Dr. Kini was able to unblock my LAD and stent both it and D2 during my procedure. I am so grateful that I felt immediate differences afterwards and was able to go home the next day. Thank you, Dr. Kini and team!