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Monoclonal Antibodies

Atibuclimab for Heart Attack

Phase 1 & 2
Waitlist Available
Research Sponsored by Implicit Bioscience
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Acute myocardial infarction with ST elevation at the J-point in two contiguous leads as determined by ECG
Symptom onset prior to PCI of ≤12 hours
Must not have
Previous major vascular intervention within the last 4 weeks
Major surgery within the last 6 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 15 minutes, 6 hours, day 4, day 15, day 22, day 29

Summary

This trial will test if giving a specific medication through a vein to adults who had a heart attack and received a stent can help protect their heart from more damage. They want to see if this medication

Who is the study for?
This trial is for adults who've had a severe type of heart attack known as ST-elevation myocardial infarction (STEMI) and have been treated with stent placement. Specific eligibility criteria are not provided, but typically participants must meet certain health standards to be included.
What is being tested?
The study is testing Atibuclimab (IC14), an anti-CD14 monoclonal antibody, given once via IV at 20 mg/kg, against a placebo consisting of 150 mL saline solution also given once via IV. The aim is to see if Atibuclimab can prevent further damage to heart muscle and improve heart function.
What are the potential side effects?
While specific side effects are not listed for this trial, monoclonal antibodies like Atibuclimab can sometimes cause allergic reactions, infusion-related discomfort, or immune system responses that may affect various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a heart attack confirmed by an ECG.
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My symptoms started less than 12 hours before my PCI.
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I am scheduled for a standard heart attack treatment including a procedure to open my heart's arteries.
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I am over 18 and can follow the study's requirements.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had major blood vessel surgery in the last 4 weeks.
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I have not had major surgery in the last 6 weeks.
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I have a long-term inflammatory condition like rheumatoid arthritis or lupus.
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I have an active cancer, but it's not skin cancer or a very early-stage cancer.
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I have severe heart failure.
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I have severe heart valve disease.
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I do not have severe heart rhythm problems or unstable blood pressure.
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I am currently experiencing bleeding from my digestive or urinary system.
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My doctor expects I have less than 1 year to live due to a non-heart related condition.
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I have experienced serious heart or lung complications.
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I am receiving or have received clot-dissolving treatment for my heart attack.
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I am scheduled for or have had a heart bypass surgery.
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I haven't taken strong immune-suppressing drugs in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 15 minutes, 6 hours, day 4, day 15, day 22, day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 15 minutes, 6 hours, day 4, day 15, day 22, day 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of treatment-emergent adverse events (safety and tolerability)
Secondary study objectives
Biomarker C-Reactive Protein
Biomarker Fibrinogen
Biomarker Interleukin 6
+10 more
Other study objectives
Immunogenicity
Pharmacodynamics
Pharmacokinetic profile of serum IC14 level, including serum half life and maximum serum concentration

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental drug interventionExperimental Treatment1 Intervention
monoclonal antibody against CD14
Group II: PlaceboPlacebo Group1 Intervention
Identical-appearing normal saline for injection, intravenous, once

Find a Location

Who is running the clinical trial?

Implicit BioscienceLead Sponsor
11 Previous Clinical Trials
130 Total Patients Enrolled
Washington University School of MedicineOTHER
1,991 Previous Clinical Trials
2,295,850 Total Patients Enrolled
The Cleveland ClinicOTHER
1,053 Previous Clinical Trials
1,371,164 Total Patients Enrolled
~7 spots leftby Jul 2025
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