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SP16 Inflammatory Response Inhibition Trial (SPIRIT)

Primary Purpose

Myocardial Infarction, Inflammation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SP16
Sponsored by
Serpin Pharma, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SP16

Arm Description

Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Diagnosis of Heart Failure
Number of participants diagnosed with heart failure at 1 year follow up

Full Information

First Posted
January 8, 2020
Last Updated
January 4, 2023
Sponsor
Serpin Pharma, LLC
Collaborators
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT04225533
Brief Title
SP16 Inflammatory Response Inhibition Trial
Acronym
SPIRIT
Official Title
SP16 Inflammatory Response Inhibition Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
January 4, 2021 (Actual)
Study Completion Date
December 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Serpin Pharma, LLC
Collaborators
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SP16
Arm Type
Experimental
Arm Description
Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
SP16
Intervention Description
All patients will receive a single dose of SP16
Primary Outcome Measure Information:
Title
Area Under the Curve (AUC) for C-reactive Protein (CRP)
Description
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.
Time Frame
Baseline, 72 hours, 14 days
Secondary Outcome Measure Information:
Title
Area Under Curve (AUC) for Creatine-Kinase Myocardial Band (CK-MB)
Description
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.
Time Frame
72 hours
Title
Change in Left Ventricular Ejection Fraction (LVEF) at Baseline and 365 Days
Description
Patients will undergo transthoracic echocardiography at baseline and 365 days to evaluate the change in LVEF.
Time Frame
365 days
Title
Diagnosis of Heart Failure
Description
Number of participants diagnosed with heart failure at 1 year follow up
Time Frame
365 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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<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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Abbate, MD, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35881895
Citation
Van Tassell BW, Wohlford GF, Del Buono MG, Damonte JI, Markley R, Turlington J, Kadariya D, Talasaz A, Ho J, Marawan A, Thomas GK, Austin D, Gineste C, Gelber C, Abbate A. Safety, Tolerability, and Effects of a Single Subcutaneous Administration of SP16 - a SERPIN-like, Small Peptide Agonist of the Low-Density Lipoprotein-like Receptor 1- on the Acute Inflammatory Response in Patients With ST-Segment Elevation Myocardial Infarction. J Cardiovasc Pharmacol. 2022 Nov 1;80(5):672-678. doi: 10.1097/FJC.0000000000001331.
Results Reference
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SP16 Inflammatory Response Inhibition Trial

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