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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

August 30, 2013
September 6, 2013
December 10, 2015
February 12, 2016
February 12, 2016
December 2013
June 2014   (Final data collection date for primary outcome measure)
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.
C reactive protein [ Time Frame: 14 days ]
Area under the curve for C reactive protein (CRP) drawn at admission, 3 days and 14 days
Complete list of historical versions of study NCT01936896 on Archive Site
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
Same as current
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.
Safety [ Time Frame: 3 months ]
We will record all adverse events (cardiac and non-cardiac) over the 3 months, including infusion reactions and drug-related issues.
Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction
Alpha-1 Anti-Trypsin (AAT) to Quench the Acute Inflammatory Response in ST-segment Elevation Acute Myocardial Infarction

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).

Not Provided
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Myocardial Infarction
Drug: Alpha 1-Antitrypsin
Other Names:
  • Prolastin C
  • Aralast NP
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)
Intervention: Drug: Alpha 1-Antitrypsin
Abouzaki NA, Christopher S, Trankle C, Van Tassell BW, Carbone S, Mauro AG, Buckley L, Toldo S, Abbate A. Inhibiting the Inflammatory Injury After Myocardial Ischemia Reperfusion With Plasma-Derived Alpha-1 Antitrypsin: A Post Hoc Analysis of the VCU-α1RT Study. J Cardiovasc Pharmacol. 2018 Jun;71(6):375-379. doi: 10.1097/FJC.0000000000000583.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2014
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 99 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Virginia Commonwealth University
Virginia Commonwealth University
Not Provided
Principal Investigator: Antonio Abbate, MD, PhD Virginia Commonwealth University
Principal Investigator: Benjamin Van Tassell, PharmD Virginia Commonwealth University
Virginia Commonwealth University
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP