Phase 2 N=30 Randomized Quadruple-blind Treatment

Anakinra to Prevent Adverse Post-infarction Remodeling (2)

Acute Myocardial Infarction · Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT01175018 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

May 2016

Primary outcome: Primary: Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices — 1.5; 1.0 mL/m2 — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Anakinra (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Virginia Commonwealth University
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices	1.5; 1.0	<0.05 sig
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	3; -4	>0.05
SECONDARY Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >5%)	45; 43	>0.05
SECONDARY Median Difference Between the 2 Arms in the Peak Oxygen Consumption (VO2) at 10-14 Weeks	-1; 2.5	>0.05
SECONDARY Incidence of Heart Failure	1; 4	<0.05 sig
SECONDARY Number of Adverse Events in Each Group	11; 20	>0.05
SECONDARY Difference Between the 2 Arm in the Interval Change in Right Ventricular Ejection Fraction (RVEF)	5; 4	>0.05
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	2; -2	>0.05
SECONDARY Median Difference Between the 2 Arms in the Ratio of Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) at 10-14 Weeks	-1; -3	>0.05
SECONDARY Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >10%)	27; 36	>0.05
SECONDARY Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >5%) Based Upon Cardiac Magnetic Resonance Imaging	55; 42	>0.05
SECONDARY Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >10%)	45; 29	>0.05
SECONDARY Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >5%	36; 36	>0.05
SECONDARY Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >10%	27; 0	>0.05
SECONDARY Number of Deaths in Each Group	0; 1	>0.05
SECONDARY Number of Adverse Events Requiring Withdrawal in Each Group	2; 2	>0.05

Summary

Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many patients die early during the course, and those who survive are at risk for dying late from adverse cardiac remodeling and heart failure. The initial ischemic damage to the myocardium initiates an intense inflammatory response in promoting further cardiac dysfunction and heart failure. The investigators propose that an antiinflammatory strategy based on blockade of Interleukin-1 will quench the inflammatory response and lead to a more favorable cardiac remodeling process.

Eligibility Criteria

Inclusion Criteria

Patients with STEMI will be asked to enroll according to the following inclusion criteria:
age > 18 years,
acute ( 2 mm) in 2 or more anatomically contiguous leads at ECG,
and successful primary percutaneous coronary intervention.

Exclusion criteria

inability to give informed consent,
late presentation (>12 h),
unsuccessful revascularization procedure,
hemodynamic instability including hypotension,
prior Q-wave AMI,
end-stage congestive heart failure (American Heart Association [AHA]/American College of Cardiology [ACC] class C-D, New York Heart Association IV), severe left ventricular dysfunction (EF 1.5 or platelet count<50000/mm3),
recent (<14 days) use of anti-inflammatory drugs (not including NSAIDs),
chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), and malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01175018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.