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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Virginia Commonwealth University
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01950299
First received: September 4, 2013
Last updated: August 22, 2016
Last verified: August 2016
  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:


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.

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

ClinicalTrials.gov processed this record on August 25, 2016