SP16 Inflammatory Response Inhibition Trial

• Status: Active, not recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Serpin Pharma, LLC; Virginia Commonwealth University
• Collaborators: Serpin Pharma, LLC; Virginia Commonwealth University

Criteria

In order to be eligible for this study, patients must meet all the 3 criteria:

1. 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);

2. 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)

3. 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