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: January 15, 2016
Last verified: January 2016
Results First Received: December 10, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Myocardial Infarction
Intervention: Drug: Alpha 1-Antitrypsin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Alpha-1 Anti-trypsin (AAT) Plasma derived Alpha 1-Antitrypsin (AAT) 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)

Participant Flow:   Overall Study
    Alpha-1 Anti-trypsin (AAT)  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Alpha-1 Anti-trypsin (AAT) Plasma derived (Alpha 1-Antitrypsin) AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)

Baseline Measures
    Alpha-1 Anti-trypsin (AAT)  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     2  
Age  
[units: years]
Median (Full Range)
  52.5   (33 to 77)  
Gender  
[units: participants]
 
Female     5  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures
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1.  Primary:   C Reactive Protein (Area Under the Curve)   [ Time Frame: 14 days ]

2.  Secondary:   Left Ventricular End-systolic Volume Change   [ Time Frame: 3 months ]

3.  Other Pre-specified:   Safety   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Antonio Abbate
Organization: Virginia Commonwealth University
phone: 8048280513
e-mail: antonio.abbate@vcuhealth.org



Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov 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