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

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ClinicalTrials.gov Identifier: NCT01936896
Recruitment Status : Completed
First Posted : September 6, 2013
Results First Posted : February 12, 2016
Last Update Posted : February 12, 2016
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:

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 or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Alpha 1-Antitrypsin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2013
Primary Completion Date : June 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. C Reactive Protein (Area Under the Curve) [ Time Frame: 14 days ]
    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 :
  1. Left Ventricular End-systolic Volume Change [ Time Frame: 3 months ]
    We will calculate the interval change between admission and 3 months in left ventricular end-systolic volume, using echocardiography

Other Outcome Measures:
  1. Safety [ Time Frame: 3 months ]
    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.

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01936896     History of Changes
Other Study ID Numbers: HM15342
First Posted: September 6, 2013    Key Record Dates
Results First Posted: February 12, 2016
Last Update Posted: February 12, 2016
Last Verified: January 2016

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