Experimental antibody aims to shield hearts after stent treatment
NCT ID NCT06678074
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a monoclonal antibody called atibuclimab (IC14) in 10 adults who had a severe heart attack (STEMI) and received a stent. The drug is given by IV to see if it can prevent further heart muscle damage and reduce inflammation. Participants are compared to those receiving a placebo to check safety and heart function improvements.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2025
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Acute myocardial infarction with ST elevation at the J-point in two contiguous leads as determined by ECG. 2. TIMI grade 0 (no flow) or grade 1 (penetration without perfusion) of the culprit artery on initial coronary angiogram 3. Symptom onset prior to PCI of ≤12 hours 4. Planned to receive the local standard of care for treatment of their STEMI and follow up which must include percutaneous coronary intervention (PCI) 5. Ability to infuse study drug within 12 hours of PCI 6. Age ≥18 years, willing and able to provide written informed consent and to comply with the protocol (i.e., reporting of symptoms) 7. Capable of completing study visits 8. Females participating in the study must meet one of the following criteria: 1. Postmenopausal (postmenopausal females must have no menstrual bleeding for at least 1 year); 2. Surgically sterilized (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) for at least 6 months; or 3. If not postmenopausal, agree to use a double method of contraception, one of which is a barrier method (e.g., intrauterine device plus condom, spermicidal gel plus condom) until 30 days after the treatment 9. Males who have not had a vasectomy must use appropriate contraception methods (barrier or abstinence) until 30 days after treatment Exclusion Criteria: An individual fulfilling any of the following criteria is to be excluded from enrollment in the study: 1. Killip Classification for Heart Failure Class III (acute pulmonary edema) or IV (cardiogenic shock) 2. Severe aortic or mitral valve disease 3. Failure to reperfuse, vascular dissection, cardiac perforation, cardiac arrest, requirement for mechanical circulatory support, or acute respiratory failure requiring ventilatory support 4. Major hemodynamic instability or uncontrolled ventricular arrhythmias 5. Planned or conducted thrombolytic therapy for treatment of this STEMI event 6. Planned or conducted coronary artery bypass graft 7. Previous major vascular intervention within the last 4 weeks 8. Major surgery within the last 6 weeks 9. Evidence of an active gastrointestinal or urogenital bleeding 10. Recent (\<14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a prednisone equivalent dose of ≥0.5 mg/kg/day but not including inhaled or low-dose oral corticosteroids, non-steroidal anti-inflammatory drugs, or colchicine). 11. Chronic inflammatory disorder (i.e., rheumatoid arthritis, systemic lupus erythematosus). 12. Active infection (of any type), including chronic/recurrent infectious disease (including HBV, HCV, and HIV/AIDS), but excluding HCV+ with undetectable plasma RNA. 13. Neutropenia (\<1,500/mm3 or \<1,000/mm3 in Black/African American patients). 14. Active malignancy, excluding carcinoma in situ \[any location\] or localized non-melanoma skin cancer 15. Participation in any study using an investigational drug or device within 30 days or within 5 half-lives of the investigational drug (whichever is longer) of entry into this study. 16. Life expectancy of less than 1 year due to non-cardiac pathology 17. History of allergic reaction to atibuclimab (IC14), any monoclonal antibody, or any other component used in the study (including contrast media) 18. Body weight \>300 pounds (weight limit of the PET/CT table) 19. Known severe renal (creatinine clearance \<30 mL/min) or hepatic insufficiency as well as alanine transaminase (ALT) elevation ≥ 3x upper limit of normal; isolated AST-elevation is not considered an exclusion criterion from study participation 20. Any clinically significant abnormality identified at the time of Screening that in the judgment of the Investigator, or any sub-Investigator would preclude safe completion of the study
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for STEMI are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Virginia
Charlottesville, Virginia, 22908-1394, United States
-
Washington University School of Medicine
St Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new CT scan see brain stents clearly enough to replace an invasive test?
- Insulin resistance may predict poor blood flow after heart attack stenting in diabetics
- Could dropping aspirin early after stent surgery be safer?
- Heart attack aftermath: which treatment causes less internal bleeding?
- Sound waves vs X-Rays: which guides heart stents better?
- Can a chinese herbal tablet help hearts heal after a heart attack?