Phase 2
N=10
SP16 Inflammatory Response Inhibition Trial
Myocardial Infarction · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT04225533 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Area Under the Curve (AUC) for C-reactive Protein (CRP) — 133 mg*day/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SP16 (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Serpin Pharma, LLC
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) for C-reactive Protein (CRP) |
133 | — |
| SECONDARY Area Under Curve (AUC) for Creatine-Kinase Myocardial Band (CK-MB) |
1432 | — |
| SECONDARY Change in Left Ventricular Ejection Fraction (LVEF) at Baseline and 365 Days |
5 | — |
| SECONDARY Diagnosis of Heart Failure |
— | — |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT04225533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.