Trial record 13 of 90 for:    heart block | Open Studies | NIH, U.S. Fed

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

This study is not yet open for participant recruitment.
Verified September 2013 by Virginia Commonwealth University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01950299
First received: September 4, 2013
Last updated: September 20, 2013
Last verified: September 2013
  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: October 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (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
Drug: Placebo
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
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)
Placebo Comparator: Placebo
Placebo for 14 days
Drug: Placebo
Other Name: Placebo injections twice daily

  Eligibility

Ages Eligible for Study:   21 Years and older
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 (AHA/ACC 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)
  • Recent (<14 days) or active use of anti-inflammatory drugs (not including NSAIDs or corticosteroids used for IV dye allergy only)
  • Chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
  • Known active malignancy of any type, or prior diagnosis in the past 10 years
  • Anticipated need for cardiac surgery
  • Active cancer (or prior diagnosis of cancer within the past 10 years)
  • Neutropenia (absolute neutrophil count<1,800/mm3)
  Contacts and Locations
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, 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         
Sponsors and Collaborators
Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01950299     History of Changes
Other Study ID Numbers: VCU HM20000024
Study First Received: September 4, 2013
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration
United States: VCU-ART3 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014