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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Virginia Commonwealth University
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01936896
First received: August 30, 2013
Last updated: December 18, 2013
Last verified: December 2013

August 30, 2013
December 18, 2013
December 2013
July 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01936896 on ClinicalTrials.gov Archive Site
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
Same as current
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.
Safety [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
October 2014
July 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 (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
Both
21 Years and older
No
Contact: Antonio Abbate, MD, PhD 8048280513 aabbate@vcu.edu
Contact: Benjamin W Van Tassell, PharmD 8049820997 bvantassell@vcu.edu
United States
 
NCT01936896
HM15342
No
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
December 2013

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