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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 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
5%
chest pain
5%
gastrointestinal bleeding
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor
1,383 Previous Clinical Trials
1,379,821 Total Patients Enrolled
3 Trials studying Acute Coronary Syndrome
2,368 Patients Enrolled for Acute Coronary Syndrome
Washington University School of MedicineOTHER
1,945 Previous Clinical Trials
2,303,725 Total Patients Enrolled
3 Trials studying Acute Coronary Syndrome
1,210 Patients Enrolled for Acute Coronary Syndrome
Johns Hopkins UniversityLead Sponsor
2,274 Previous Clinical Trials
14,840,418 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
~7 spots leftby Oct 2024
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