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

This study has been completed.
Information provided by (Responsible Party):
Virginia Commonwealth University Identifier:
First received: August 30, 2013
Last updated: January 15, 2016
Last verified: January 2016

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 (Area Under the Curve) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    A single area under the curve (AUC) calculation based upon C-reactive protein (CRP) values drawn at baseline, 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


Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 (American Heart Association/American College of Cardiology 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
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Please refer to this study by its identifier: NCT01936896

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

Responsible Party: Virginia Commonwealth University Identifier: NCT01936896     History of Changes
Other Study ID Numbers: HM15342 
Study First Received: August 30, 2013
Results First Received: December 10, 2015
Last Updated: January 15, 2016
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

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
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 processed this record on October 28, 2016