Evolocumab for Acute Coronary Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Acute Coronary Syndrome
Evolocumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Acute Coronary Syndrome

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Baseline, 25-30 days

Baseline, 25-30 days
Change in LDL-Cholesterol
Baseline, 30 days
Change in PET Imaging for inflammation

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Acute Coronary Syndrome

Side Effects for

HPR - Evolocumab
5%chest pain
5%gastrointestinal bleeding
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03096288) in the HPR - Evolocumab ARM group. Side effects include: chest pain with 5%, gastrointestinal bleeding with 5%.

Trial Design

2 Treatment Groups

Evolocumab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

100 Total Participants · 2 Treatment Groups

Primary Treatment: Evolocumab · Has Placebo Group · Phase 2

Evolocumab
Drug
Experimental Group · 1 Intervention: Evolocumab · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebos · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evolocumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 25-30 days

Who is running the clinical trial?

AmgenIndustry Sponsor
1,291 Previous Clinical Trials
1,306,954 Total Patients Enrolled
3 Trials studying Acute Coronary Syndrome
2,368 Patients Enrolled for Acute Coronary Syndrome
Johns Hopkins UniversityLead Sponsor
2,055 Previous Clinical Trials
30,974,881 Total Patients Enrolled
4 Trials studying Acute Coronary Syndrome
360 Patients Enrolled for Acute Coronary Syndrome
Washington University School of MedicineOTHER
1,789 Previous Clinical Trials
2,271,776 Total Patients Enrolled
3 Trials studying Acute Coronary Syndrome
1,210 Patients Enrolled for Acute Coronary Syndrome
Thorsten Leucker, MD, PhDPrincipal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have ST elevation myocardial infarction, with compatible symptoms and ECG changes.
You are able to understand the risks and benefits of participation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: October 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.