Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction (VCU-Alpha1RT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01936896
First received: August 30, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

Acute myocardial infarction is characterized by an intense inflammatory response.

The degree of the response influences clinical outcome, with 'more' inflammation promoting heart failure. In this study we plan to determine whether treatment with plasma derived alpha-1 antitrypsin will quench the inflammatory response in patients with acute ST-segment elevation myocardial infarction (STEMI).


Condition Intervention Phase
Acute Myocardial Infarction
Drug: Alpha 1-Antitrypsin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Alpha-1 Anti-Trypsin (AAT) to Quench the Acute Inflammatory Response in ST-segment Elevation Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • C reactive protein [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Area under the curve for C reactive protein (CRP) drawn at admission, 3 days and 14 days


Secondary Outcome Measures:
  • Left ventricular end-systolic volume change [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    We will calculate the interval change between admission and 3 months in left ventricular end-systolic volume, using echocardiography


Other Outcome Measures:
  • Safety [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    We will record the number of participants with all adverse events (cardiac and non-cardiac) over the 3 months, including infusion reactions and drug-related issues.


Enrollment: 10
Study Start Date: December 2013
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alpha-1 anti-trypsin (AAT)
We will use plasma derived AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
Drug: Alpha 1-Antitrypsin
Other Names:
  • Prolastin C
  • Aralast NP

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and ECG evidence of ST segment elevation (>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new
  • Planned or completed coronary angiogram for potential intervention
  • Age>21

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
  • Preexisting congestive heart failure (AHA/ACC class C-D, New York Heart Association III-IV)
  • Preexisting severe left ventricular dysfunction (EF<20%)
  • Preexisting severe valvular heart disease
  • Known active infections (acute or chronic)
  • 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
  • Anticipated need for cardiac or major surgery
  • Known active cancer (or prior diagnosis of cancer within the past 10 years)
  • Known Immunoglobulin A (IgA) deficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936896

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Antonio Abbate, MD, PhD Virginia Commonwealth University
Principal Investigator: Benjamin Van Tassell, PharmD Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01936896     History of Changes
Other Study ID Numbers: HM15342
Study First Received: August 30, 2013
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration
United States: IRB Panel D, Virginia Commonwealth University

Keywords provided by Virginia Commonwealth University:
Acute myocardial infarction
Heart Failure
Inflammation

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Alpha 1-Antitrypsin
Protein C Inhibitor
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014