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Monoclonal Antibodies

Evolocumab for Acute Coronary Syndrome (EVACS II Trial)

Phase 2

Waitlist Available

Led By Thorsten Leucker, MD, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Non ST elevation myocardial infarction, with a troponin I > 5ng/mL and with compatible symptoms and ECG changes

Age 25 to 90 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 25-30 days

Awards & highlights

EVACS II Trial Summary

This trial is testing whether or not adding a PCSK9 antibody to current medical therapies would help patients with an ACS by reducing LDL-C, stabilizing vulnerable plaque, and limiting inflammation-associated myocardial cell loss and resultant dysfunction.

Who is the study for?

This trial is for adults aged 25-90 with Acute Coronary Syndrome who've had a recent heart attack, confirmed by symptoms and tests. They must understand the study's risks and benefits. Excluded are those planning heart surgery, in another drug study, allergic to latex, non-English speakers, women at risk of pregnancy not using birth control (unless sterilized or postmenopausal), anyone unlikely to follow the study plan or already on PCSK9 antibody treatment.Check my eligibility

What is being tested?

The trial is testing Evolocumab—a drug that lowers 'bad' cholesterol and may reduce inflammation after a heart attack—against a placebo. The goal is to see if it can stabilize damaged areas in the heart and limit further harm by reducing cholesterol levels.See study design

What are the potential side effects?

Evolocumab might cause reactions like cold-like symptoms, back pain, high blood pressure, or injection site reactions. It could also lead to more serious issues such as muscle problems or an allergic reaction.

EVACS II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had a heart attack without ST elevation, with high troponin I levels and matching symptoms and ECG changes.

Select...

I am between 25 and 90 years old.

Select...

I have had a heart attack with specific ECG changes.

EVACS II Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 25-30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 25-30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 25-30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in LDL-Cholesterol

Secondary outcome measures

Change in PET Imaging for inflammation

Side effects data

From 2020 Phase 4 trial • 259 Patients • NCT03096288

chest pain

gastrointestinal bleeding

100%

80%

60%

40%

20%

Study treatment Arm

HPR - Evolocumab

HPR - Placebo

NPR - Evolocumab

NPR - Placebo

EVACS II Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EvolocumabExperimental Treatment1 Intervention

420 mg evolocumab administered subcutaneously using an autoinjector/pen in ACS patients.

Group II: PlaceboPlacebo Group1 Intervention

Placebo administered subcutaneously using an autoinjector/pen in ACS patients .

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Evolocumab

2011

Completed Phase 4

~13010

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor

1,370 Previous Clinical Trials

1,377,588 Total Patients Enrolled

3 Trials studying Acute Coronary Syndrome

2,368 Patients Enrolled for Acute Coronary Syndrome

Washington University School of MedicineOTHER

1,931 Previous Clinical Trials

2,299,609 Total Patients Enrolled

3 Trials studying Acute Coronary Syndrome

1,210 Patients Enrolled for Acute Coronary Syndrome

Johns Hopkins UniversityLead Sponsor

2,256 Previous Clinical Trials

14,819,971 Total Patients Enrolled

4 Trials studying Acute Coronary Syndrome

360 Patients Enrolled for Acute Coronary Syndrome

Media Library

Evolocumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04082442 — Phase 2

Acute Coronary Syndrome Research Study Groups: Placebo, Evolocumab

Acute Coronary Syndrome Clinical Trial 2023: Evolocumab Highlights & Side Effects. Trial Name: NCT04082442 — Phase 2

Evolocumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04082442 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any long-term risks associated with Evolocumab?

"Evolocumab's safety is rated at a 2 because, while there is some data supporting its safety profile, none of the available information suggests that it is an effective medication."

Answered by AI

Is this a novel clinical trial?

"As of right now, there are 23 ongoing Evolocumab studies in 240 different cities and 35 countries. The first trial was held in 2018 and completed Phase 1 & 2 drug approval. It is worth noting that since the initial study, 291 more have been completed."

Answered by AI

Does this research include patients that are over the age of 50?

"In order for patients to be eligible for this clinical trial, they must between the ages of 25 and 90. There are 4 other trials available for children under 18 and 161 options for adults over 65."

Answered by AI

Could I be a potential candidate for this research project?

"We are looking for 100 individuals aged 25 to 90 years old that have experienced acute coronary syndrome. Other requirements include: having their attending physician's permission, being able to understand the benefits and risks of participating, and more."

Answered by AI

What is the total sample size for this experiment?

"That is correct. The clinicaltrials.gov website indicates that this trial, which was first posted on September 1st 2019, 100 patients at 1 location."

Answered by AI

Are people still able to join this trial at this time?

"That is accurate. The clinical trial, which can be found on clinicaltrials.gov, is currently looking for participants. The study was originally posted on September 1st 2019 and was most recently edited on June 17th 2022. They are aiming to recruit 100 patients from 1 site."

Answered by AI

Recent research and studies

The American Journal of CardiologyJournal

The Trajectory of Lipoprotein(a) During the Peri- and Early Postinfarction Period and the Impact of Proprotein Convertase Subtilisin/kexin Type 9 Inhibition

Vavuranakis, Michael A., Steven R. Jones, Efthymios Ziogos, Michael J. Blaha, Marlene S. Williams, Palmer Foran, Thomas H. Schindler, et al.. 2022. “The Trajectory of Lipoprotein(a) During the Peri- and Early Postinfarction Period and the Impact of Proprotein Convertase Subtilisin/kexin Type 9 Inhibition”. The American Journal of Cardiology. Elsevier BV. doi:10.1016/j.amjcard.2022.01.058.

clinicaltrials.govStudy

Evolocumab in Patients With Acute MI

2019. "Evolocumab in Patients With Acute MI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04082442.