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Anakinra to Prevent Adverse Post-infarction Remodeling (2)

NCT01175018Phase 2

Key facts

Status: Completed
Start: Jul 2010
Primary completion: Sep 2012
Countries: 1
Sponsor: Virginia Commonwealth University
Modality: Cytokines & Interferons

Drugs: anakinra
Conditions: acute myocardial infarction (AMI)

Overview

Phase 2, randomised trial in acute myocardial infarction (AMI) comparing Anakinra with Placebo (2 arms). Primary endpoint: Change in Left Ventricular End-systolic Volume Indices. Started Jul 2010; status: completed.

Design

2 arms

Study design: Randomized

Anakinra
Anakinra 100 mg s.c. daily for 14 days
Placebo
0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days

Who it enrols

Patients >18 years with acute (<12 h) STEMI and successful primary PCI, excluding those with severe left ventricular dysfunction, end-stage heart failure, coagulopathy, or recent use of anti-inflammatory drugs.

Endpoints

Primary

Change in Left Ventricular End-systolic Volume Indices10-14 weeks

Secondary

Change in Left Ventricular End-diastolic Volume Indices10-14 weeks
Percentage of Patients With Reverse Remodeling (Reduction in LVESVi >5%)10-14 weeks
Peak Oxygen Consumption10-14 weeks
Incidence of Heart Failure10-14 weeks
Number of Adverse Events10-14 weeks
Interval Change in Right Ventricular Ejection Fraction10-14 weeks
Change in Left Ventricular Ejection Fraction Values10-14 weeks
Ratio of Minute Ventilation and Carbon Dioxide Production10-14 weeks

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