Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
10 participants
INTERVENTIONAL
2008-11-30
2009-08-31
Brief Summary
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Current interventions proven to reduce adverse remodeling and progression to heart failure include early reperfusion (restoring blood flow to the heart muscle) and long-term use of medicines that block the effects of hormones (such as angiotensin II, norepinephrine and aldosterone) involved in adverse remodeling. Despite these treatments, however, many patients continue to develop heart failure within 1 year of AMI. These patients are at very high risk of death.
Numerous changes occur in the hearts of patients after AMI that lead to adverse remodeling. Ischemia (lack of oxygen) and infarction (cell damage) lead to increased interleukin-1 (IL-1) production in the heart. IL-1 plays a critical role in adverse cardiac remodeling by coordinating the inflammatory pathway (leading to wound healing) and apoptotic pathway (leading to cell death).
In opposition to IL-1 activity, the human body produces a natural IL-1 receptor antagonist that blocks the effects of IL-1. The drug form of this IL-1 receptor antagonist (anakinra) is currently FDA approved for the treatment of rheumatoid arthritis, an inflammatory disease characterized by excessive IL-1 activity. Experimental studies show that anakinra is able to prevent cardiac remodeling and improve survival in mice after AMI.
We hypothesize that anakinra will show similar benefits in human patients by preventing adverse remodeling and heart failure after AMI.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Anakinra
Anakinra 100 mg given daily by subcutaneous injection for 14 days
Anakinra
100 mg daily subcutaneous injection for 14 days
Placebo
0.67 ml of NaCl 0.9% solution
Placebo
0.67 ml of NaCl 0.9% subcutaneously daily for 14 days
Interventions
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Anakinra
100 mg daily subcutaneous injection for 14 days
Placebo
0.67 ml of NaCl 0.9% subcutaneously daily for 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute (\<24 hours) onset of chest pain
* New or presumably new ST elevation on ECG
* Planned coronary angiography for percutaneous revascularization
Exclusion Criteria
* Late presentation (\>24 hours)
* Unsuccessful revascularization or urgent coronary bypass surgery
* Hemodynamic instability
* End-stage congestive heart failure (AHA/ACC stage C/D, NYHA class IV)
* Preexisting severe LV dysfunction (LVEF\<20%) or severe valvular disease
* Severe asthma
* Pregnancy ( pre-enrollment pregnancy test)
* Contraindications to cardiac MRI or cardiac angiography
* Severe coagulopathy (INR\>2.0, Platelet count\<50,000/mm3)
* Severe renal insufficiency (creatinine clearance \<30 ml/min/m2)
* Recent (\<14 days) use of anti-inflammatory drugs (NSAIDS excluded)
* Chronic inflammatory disease
18 Years
ALL
No
Sponsors
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Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Antonio Abbate, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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Denicolai M, Morello M, Golino M, Corna G, Del Buono MG, Agatiello CR, Van Tassell BW, Abbate A. Interleukin-1 Blockade in Patients With ST-Segment Elevation Myocardial Infarction Across the Spectrum of Coronary Artery Disease Complexity. J Cardiovasc Pharmacol. 2025 Mar 1;85(3):200-210. doi: 10.1097/FJC.0000000000001652.
Del Buono MG, Damonte JI, Chiabrando JG, Markley R, Turlington J, Trankle CR, Kang L, Biondi-Zoccai G, Van Tassell BW, Abbate A. Effect of IL-1 Blockade With Anakinra on Heart Failure Outcomes in Patients With Anterior Versus Nonanterior ST Elevation Myocardial Infarction. J Cardiovasc Pharmacol. 2022 Jun 1;79(6):774-780. doi: 10.1097/FJC.0000000000001240.
Abbate A, Kontos MC, Abouzaki NA, Melchior RD, Thomas C, Van Tassell BW, Oddi C, Carbone S, Trankle CR, Roberts CS, Mueller GH, Gambill ML, Christopher S, Markley R, Vetrovec GW, Dinarello CA, Biondi-Zoccai G. Comparative safety of interleukin-1 blockade with anakinra in patients with ST-segment elevation acute myocardial infarction (from the VCU-ART and VCU-ART2 pilot studies). Am J Cardiol. 2015 Feb 1;115(3):288-92. doi: 10.1016/j.amjcard.2014.11.003. Epub 2014 Nov 13.
Other Identifiers
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VCU-ART
Identifier Type: -
Identifier Source: org_study_id