Evolocumab in Patients With Acute MI

NCT04082442 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00206305
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Vascular and myocardial inflammation are significantly increased in Acute Coronary Syndrome (ACS) patients, are closely correlated to LDL-C levels, and are associated with these adverse consequences in the post-ACS patient population. Serum proprotein convertase subtilisin/kerin type 9 (PCSK9) levels are also increased in ACS, may raise LDL-C, and the investigators' pre-clinical studies indicate that PCSK9 is also a potent inducer of vascular inflammation. The addition of the PCSK9 antibody evolocumab, currently approved to lower LDL-C in certain patient populations, to current medical therapies would appear to be of particular benefit in patients with an ACS by markedly reducing LDL-C, stabilizing vulnerable plaque, and limiting inflammation-associated myocardial cell loss and resultant dysfunction.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in LDL-Cholesterol

  The difference, in the percent change in LDL-cholesterol (mg/dL), from baseline to the 25-30 day values.

  Baseline, 25-30 days

Secondary Outcomes (1)

• FDG-PET Imaging Analysis of Inflammation as Mean Standardized Uptake Value (SUV)

  Baseline, 30 days

Study Arms (2)

Evolocumab

EXPERIMENTAL

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

Drug: Evolocumab

Placebo

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Evolocumab DRUG

420 mg evolocumab.

Evolocumab

Placebos DRUG

Matching placebo.

Placebo

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 25 to 90 years.
• ST elevation myocardial infarction, with compatible symptoms and ECG changes.
• Non ST elevation myocardial infarction, with a troponin I \> 5ng/mL and with compatible symptoms and ECG changes.
• Permission of attending physician.
• Ability to understand the risk, benefits, and alternatives of participation.

You may not qualify if:

• Scheduled for cardiac surgery.
• Current treatment with a PCSK9 antibody.
• Current participation in an intervention clinical trial.
• Latex allergy
• Previous adverse reaction to monoclonal antibodies
• Non-English speaking
• Female of childbearing potential. This is a female subject who has not used acceptable method(s) of birth control (see below) for at least one month prior to screening, unless the subject is sterilized or postmenopausal. Menopause is defined as: 12 months of spontaneous and continuous amenorrhea in a female \> 55 year of age.
• Acceptable method(s) of birth control definition: One highly effective method (methods that can achieve a failure rate of less than 1% per year when used consistently and correctly)
• Combined hormonal (estrogen and progestogen) contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
• Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
• Intrauterine device (IUD)
• Intrauterine hormone-releasing system (IUS)
• Bilateral tubal occlusion
• Vasectomized partner
• Sexual abstinence

Sponsors & Collaborators

• Johns Hopkins University: lead
• Amgen: collaborator

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• Ziogos E, Vavuranakis MA, Harb T, Foran PL, Blaha MJ, Jones SR, Lai S, Gerstenblith G, Leucker TM. Lipoprotein(a) concentrations in acute myocardial infarction patients are not indicative of levels at six month follow-up. Eur Heart J Open. 2023 Apr 5;3(2):oead035. doi: 10.1093/ehjopen/oead035. eCollection 2023 Mar.

  PMID: 37095769 DERIVED

• Vavuranakis MA, Jones SR, Ziogos E, Blaha MJ, Williams MS, Foran P, Schindler TH, Lai S, Schulman SP, Gerstenblith G, Leucker TM. The Trajectory of Lipoprotein(a) During the Peri- and Early Postinfarction Period and the Impact of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition. Am J Cardiol. 2022 May 15;171:1-6. doi: 10.1016/j.amjcard.2022.01.058. Epub 2022 Mar 21.

  PMID: 35314069 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Thorsten Leucker, MD
• Organization: Johns Hopkins University

tleucke1@jhmi.edu

410-502-0469

Study Officials

• Thorsten Leucker, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: September 1, 2019
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: October 23, 2025
• Results First Posted: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)