Anakinra to Prevent Adverse Post-infarction Remodeling (2)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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. Interleukin-1 (IL-1) is the prototypical inflammatory cytokine involved in the tissue response to injury. In the experimental model of large anterior wall AMI in the mouse, IL-1 blockade using anakinra, a recombinant human IL-1 receptor antagonist ameliorates cardiac remodeling and improves survival following AMI. Although the mouse AMI model is helpful in understanding the events leading to adverse post-infarction cardiac remodeling and heart failure, the exact role of IL-1 in patients with AMI has not been completely characterized. The investigators propose to address this question by studying patients presenting with ST-segment elevation AMI (STEMI). Such patients are at high risk for in-hospital and long-term mortality and display several markers of inflammation. The investigators hypothesize that IL-1 blockade in patients STEMI with will limit the acute inflammatory response and prevent adverse cardiac remodeling, heart failure, and related morbidity.

The investigators hypothesize that treatment with anakinra will lead to more favorable cardiac remodeling. Left ventricular end-systolic volume index (LVESVi) is the preferred clinical marker of adverse cardiac remodeling and a strong predictor of heart failure-related mortality in patients with STEMI, and will be used as primary endpoint of the study. The investigators propose that anakinra will reduce the change in LVESVi from baseline to 10-14 weeks after STEMI, and will prevent, at least in part, other changes in cardiac function and exercise tolerance associated with adverse cardiac remodeling and heart failure.

Conditions

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Acute Myocardial Infarction Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Anakinra

Anakinra 100 mg injectable subcutaneously daily

Group Type EXPERIMENTAL

Anakinra

Intervention Type DRUG

Anakinra 100 mg s.c. daily for 14 days

Placebo

0.67 ml of sodium chloride (NaCl) 0.9% solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days

Interventions

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Anakinra

Anakinra 100 mg s.c. daily for 14 days

Intervention Type DRUG

Placebo

0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days

Intervention Type DRUG

Other Intervention Names

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Kineret NaCl 0.9%

Eligibility Criteria

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Inclusion Criteria

* age \> 18 years,
* acute (\<12 h) onset of chest pain associated with ST segment elevation (\>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\<20%),
* severe valvular heart disease,
* pregnancy, dye allergy or contraindications to cardiac angiography and/or magnetic resonance imaging, coagulopathy (INR\>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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No