Interleukin-1 (IL-1) Blockade in Acute Myocardial Infarction (VCU-ART3)

Acute Myocardial Infarction Clinical Trial

— VCU-ART3  

Official title:

Interleukin-1 Blockade With Anakinra in Patients With ST-segment Elevation Myocardial Infarction - the Virginia Commonwealth University Anakinra Remodeling Trial 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950299
• Other study ID #: HM20000024
• Secondary ID: 1R34HL121402-01
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 1, 2014
• Est. completion date: December 23, 2018

Study information

• Verified date: December 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

VCU-ART3 is a double-blind randomized clinical trial of anakinra high dose vs anakinra standard dose vs placebo in patients with ST-segment elevation myocardial infarction (STEMI) measuring the effects on the acute rise and fall of the plasma C reactive protein levels during the first 14 days.

Description:

VCU-ART3 is a double-blind randomized clinical trial of anakinra high dose vs anakinra standard dose vs placebo in patients with ST-segment elevation myocardial infarction (STEMI) measuring the effects on the acute rise and fall of the plasma C reactive protein levels during the first 14 days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 23, 2018
• Est. primary completion date: December 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

INCLUSION CRITERIA:

In order to be eligible for this study, patients must meet ALL the 3 Inclusion criteria and NONE of the Exclusion criteria.

1. Acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and ECG evidence of ST segment elevation (>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new

2. Planned or completed coronary angiogram for potential intervention

3. Age>21

EXCLUSION CRITERIA:

• Inability to give informed consent

• Pregnancy

• Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV)

• Preexisting severe left ventricular dysfunction (EF<20%)

• Preexisting severe valvular heart disease

• Active infections (acute or chronic) - excluding Hepatitis C Virus (HCV)+ with undetectable RNA

• Recent (<14 days) or active use of anti-inflammatory drugs (not including non-steroidal anti-inflammatory drugs [NSAIDs] or corticosteroids used for IV dye allergy only)

• Chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)

• Active malignancy - excluding carcinoma in situ [any organ] and non-melanoma skin cancer

• Anticipated need for cardiac surgery

• Neutropenia (absolute neutrophil count<1,800/mm3)

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Anakinra 100 mg
Anakinra 100 mg starting immediately and then every 24 hours
• Anakinra 100 mg
Anakinra 100 mg starting 12 hours after first dose and then every 24 hours (so that Anakinra is given every 12 hours)
• Placebo
Placebo 0.67 ml injections twice daily

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Phase Response (CRP Levels)	Comparison of area-under-the-curve for CRP up to day 14	14 days
Secondary	Left Ventricular End-systolic Volume	Placebo corrected interval change in left ventricular end-systolic volume over 12 months	12 months
Secondary	Left Ventricular Ejection Fraction	Placebo-corrected interval changes in left ventricular ejection fraction over 12 months	12 months
Secondary	Heart Failure	New onset of heart failure symptoms (NYHA II-IV)	12 months