Anakinra to Prevent Adverse Post-infarction Remodeling (2) (VCU-ART2)

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01175018
First received: July 30, 2010
Last updated: May 9, 2016
Last verified: May 2016
Results First Received: October 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Acute Myocardial Infarction
Heart Failure
Interventions: Drug: Anakinra
Drug: Placebo

  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
Anakinra Anakinra 100 mg injectable subcutaneously daily
Placebo 0.67 ml of sodium chloride (NaCl) 0.9% solution

Participant Flow:   Overall Study
    Anakinra     Placebo  
STARTED     15     15  
COMPLETED     12     14  
NOT COMPLETED     3     1  
Adverse Event                 3                 1  



  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
Anakinra Anakinra 100 mg injectable subcutaneously daily
Placebo 0.67 ml of NaCl 0.9% solution
Total Total of all reporting groups

Baseline Measures
    Anakinra     Placebo     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     11     10     21  
>=65 years     4     5     9  
Age  
[units: years]
Mean (Standard Deviation)
  59  (12)     58  (12)     59  (12)  
Gender  
[units: participants]
     
Female     5     2     7  
Male     10     13     23  
Region of Enrollment  
[units: participants]
     
United States     15     15     30  



  Outcome Measures
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1.  Primary:   Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices   [ Time Frame: 10-14 weeks minus baseline ]

2.  Secondary:   Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-diastolic Volume Indices From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging   [ Time Frame: 10-14 weeks ]

3.  Secondary:   Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >5%)   [ Time Frame: 10-14 weeks ]

4.  Secondary:   Median Difference Between the 2 Arms in the Peak Oxygen Consumption (VO2) at 10-14 Weeks   [ Time Frame: 10-14 weeks ]

5.  Secondary:   Incidence of Heart Failure   [ Time Frame: 10-14 weeks ]

6.  Secondary:   Number of Adverse Events in Each Group   [ Time Frame: 10-14 weeks ]

7.  Secondary:   Difference Between the 2 Arm in the Interval Change in Right Ventricular Ejection Fraction (RVEF)   [ Time Frame: 10-14 weeks ]

8.  Secondary:   Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging   [ Time Frame: 10-14 weeks ]

9.  Secondary:   Median Difference Between the 2 Arms in the Ratio of Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) at 10-14 Weeks   [ Time Frame: 10-14 weeks ]

10.  Secondary:   Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >10%)   [ Time Frame: 10-14 weeks ]

11.  Secondary:   Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >5%) Based Upon Cardiac Magnetic Resonance Imaging   [ Time Frame: 10-14 weeks ]

12.  Secondary:   Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >10%)   [ Time Frame: 10-14 weeks ]

13.  Secondary:   Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >5%   [ Time Frame: 10-14 weeks ]

14.  Secondary:   Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >10%   [ Time Frame: 10-14 weeks ]

15.  Secondary:   Number of Deaths in Each Group   [ Time Frame: 10-14 weeks ]

16.  Secondary:   Number of Adverse Events Requiring Withdrawal in Each Group   [ Time Frame: 10-14 weeks ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Antonio Abbate
Organization: Virginia Commonwealth University
phone: 804-828-0513
e-mail: aabbate@mcvh-vcu.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01175018     History of Changes
Other Study ID Numbers: AHA 10SDG3030051
Study First Received: July 30, 2010
Results First Received: October 22, 2013
Last Updated: May 9, 2016
Health Authority: United States: Institutional Review Board