We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01936896
First Posted: September 6, 2013
Last Update Posted: February 12, 2016
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.
Information provided by (Responsible Party):
Virginia Commonwealth University
Results First Submitted: December 10, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Acute Myocardial Infarction
Intervention: Drug: Alpha 1-Antitrypsin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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.
No text entered.

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) 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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
First Submitted: August 30, 2013
First Posted: September 6, 2013
Results First Submitted: December 10, 2015
Results First Posted: February 12, 2016
Last Update Posted: February 12, 2016