SP16 Inflammatory Response Inhibition Trial

Study Overview
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Brief Summary
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This study will evaluate the potential benefit of blocking inflammation during a heart attack using an investigational anti-inflammatory medicine called SP16. The study will enroll 10 patients and all 10 patients will receive a standard dose of SP16.

Detailed Description
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The main hypothesis of this study is that a single subcutaneous administration of SP16 0.2 mg/kg is safe and well tolerated in patients with ST segment elevation myocardial infarction (STEMI) and associated with a reduction in the acute inflammatory response to STEMI, as measured as area-under-the-curve (AUC) for C reactive protein (CRP), the preferred inflammatory marker for cardiovascular risk prognostication. SP16 will be administered subcutaneously as this route has greater ease of administration than intravenous injection. A single dose administration has been selected based upon pre-clinical data and expected clinical use of SP16.

Official Title
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SP16 Inflammatory Response Inhibition Trial

Conditions
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Myocardial Infarction, Inflammation

Intervention / Treatment
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* Drug: SP16


Participation Criteria
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Eligibility Criteria
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In order to be eligible for this study, patients must meet all the 3 criteria: Presentation to the hospital with acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and electrocardiogram (ECG) evidence of ST segment elevation (>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new (for intermittent pain lasting more than 12 hours, the time from the when the pain became severe and constant); Coronary intervention planned and/or completed within 12 hours of symptom onset, and enrollment in the study within 6 hours of angiogram (max 18 hours from symptom onset) Age>21 years In order to be eligible for this study, patients must meet none of the Exclusion criteria. Inability to give informed consent Hemodynamic instability as defined as need for inotropic or vasoactive agents, or need for mechanical support devices (including intra-aortic balloon pump) Pregnancy or breastfeeding Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV) Preexisting severe left ventricular dysfunction (LVEF<20%) Preexisting severe valvular heart disease Known active infections (acute or chronic) Recent (<14 days) or active use of immunosuppressive drugs (including but not limited to high-dose corticosteroids [>1 mg/kg of prednisone equivalent], tumor necrosis factor-alpha blockers, cyclosporine) not including non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids used for intravenous (IV) dye allergy only) Recent (<14 days) or active use of anti-inflammatory drugs (not including NSAIDs or corticosteroids used for IV dye allergy only) Known chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus) Known active malignancy of any type, or prior diagnosis in the past 10 years Neutropenia (absolute neutrophil count<1,800/mm3 [or <1,000/mm3 in African American patients]) Severe impairment in renal function (estimated glomerular filtration rate <30 ml/kg*min) Anticipated need for cardiac or major surgery Known Allergy to SP16
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SP16<br>Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection | Drug: SP16<br>* All patients will receive a single dose of SP16<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC) for C-reactive Protein (CRP) | This study will evaluate the anti-inflammatory effect of SP16 by calculating the AUC for CRP. This is done by measuring CRP at baseline, 72 hours, and 14 days. The AUC will then be compared to historical controls to evaluate whether or not SP16 reduces the AUC for CRP. | Baseline, 72 hours, 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve (AUC) for Creatine-Kinase Myocardial Band (CK-MB) | This study will estimate the infarct size based upon area under the curve (AUC) for creatine-kinase myocardial band (CK-MB). The AUC calculation will come from CK-MB levels drawn during usual care. The infarct size will then be compared to historical controls to evaluate whether or not SP16 reduces the infarct size. | 72 hours | 
| Change in Left Ventricular Ejection Fraction (LVEF) at Baseline and 365 Days | Patients will undergo transthoracic echocardiography at baseline and 365 days to evaluate the change in LVEF. | 365 days | 
| Diagnosis of Heart Failure | Number of participants diagnosed with heart failure at 1 year follow up | 365 days |