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

Purpose

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.

Condition	Intervention	Phase
Acute Myocardial Infarction	Drug: Anakinra 100 mg Drug: Placebo	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Interleukin-1 Blockade With Anakinra in Patients With ST-segment Elevation Myocardial Infarction - the Virginia Commonwealth University Anakinra Remodeling Trial 3

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

Drug Information available for: Anakinra

U.S. FDA Resources

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:

Acute phase response (CRP levels) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Placebo corrected difference in the area-under-the-curve for CRP up to day 14

Secondary Outcome Measures:

Left ventricular end-systolic volume indices change [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Placebo corrected interval change in left ventricular end-systolic volume indices over 12 months
Left ventricular ejection fraction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Placebo-corrected interval changes in left ventricular ejection fraction over 12 months
Heart Failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
New onset of heart failure symptoms (NYHA II-IV)


Estimated Enrollment:	99
Study Start Date:	July 2014
Estimated Study Completion Date:	September 2017
Estimated Primary Completion Date:	June 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Anakinra (standard dose) Anakinra 100 mg daily for 14 days	Drug: Anakinra 100 mg Anakinra 100 mg starting immediately and then every 24 hours Other Name: Kineret Drug: Placebo Placebo 0.67 ml injections twice daily Other Name: Placebo injections twice daily
Experimental: Anakinra (high dose) Anakinra 100 mg twice daily for 14 days	Drug: Anakinra 100 mg Anakinra 100 mg starting immediately and then every 24 hours Other Name: Kineret Drug: 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) Other Name: Kineret
Placebo Comparator: Placebo Placebo for 14 days	Drug: Placebo Placebo 0.67 ml injections twice daily Other Name: Placebo injections twice daily

Detailed 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

Eligibility


Ages Eligible for Study:	21 Years to 99 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

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

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
Planned or completed coronary angiogram for potential intervention
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 (or prior malignancy within the past 10 years) - excluding carcinoma in situ [any organ] and non-melanoma skin cancer
Anticipated need for cardiac surgery
Neutropenia (absolute neutrophil count<1,800/mm3)
Need for vaccination or desensitization that cannot be postponed for 14 days

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950299

Contacts


Contact: Antonio Abbate, MD, PhD	804-828-0513	aabbate@vcu.edu
Contact: Benjamin W Van Tassell, PharmD	804-828-4583	bvantassell@vcu.edu

Locations


United States, District of Columbia
Washington Hospital Center	Recruiting
Washington DC, District of Columbia, United States, 20010
Contact: Ron Waksman, MD 202-877-5975 Ron.Waksman@Medstar.net
Contact: Michael J Lipinski, MD, PhD 202-877-5975
United States, Virginia
Virginia Commonwealth University	Not yet recruiting
Richmond, Virginia, United States, 23298
Contact: Antonio Abbate, MD, PhD 804-828-0513 aabbate@vcu.edu
Principal Investigator: Antonio Abbate, MD, PhD
Principal Investigator: Benjamin Van Tassell, PharmD
Virginia Commonwealth University	Recruiting
Richmond, Virginia, United States, 23298
Contact: Antonio Abbate, MD, PhD 804-828-0513 aabbate@vcu.edu
Principal Investigator: Antonio Abbate, MD, PhD

Sponsors and Collaborators

Virginia Commonwealth University

National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)

Investigators


Principal Investigator:	Antonio Abbate, MD, PhD	Virginia Commonwealth University

More Information


Responsible Party:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT01950299 History of Changes
Other Study ID Numbers:	VCU HM20000024 1R34HL121402-01
Study First Received:	September 4, 2013
Last Updated:	August 22, 2016
Health Authority:	United States: Food and Drug Administration United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:


Infarction Myocardial Infarction Myocardial Ischemia Heart Diseases Ischemia Pathologic Processes	Necrosis Cardiovascular Diseases Vascular Diseases Interleukin 1 Receptor Antagonist Protein Antirheumatic Agents

ClinicalTrials.gov processed this record on September 30, 2016

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