SP16 Inflammatory Response Inhibition Trial

Myocardial Infarction Clinical Trial

— SPIRIT  

Official title:

SP16 Inflammatory Response Inhibition Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04225533
• Other study ID #: HM20018201
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 24, 2020
• Est. completion date: December 21, 2021

Study information

• Verified date: January 2023
• Source: Serpin Pharma, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 21, 2021
• Est. primary completion date: January 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Inflammation
• Myocardial Infarction

Intervention

Drug:
• SP16
All patients will receive a single dose of SP16

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Serpin Pharma, LLC	Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Diagnosis of Heart Failure	Number of participants diagnosed with heart failure at 1 year follow up	365 days