Interleukin-1 (IL-1) Blockade in Acute Myocardial Infarction (VCU-ART3)
NCT01950299 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 99
Last updated 2019-12-18
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.
Conditions
- Acute Myocardial Infarction
Interventions
- 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)
- DRUG
-
Placebo 0.67 ml injections twice daily
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Virginia Commonwealth University
lead OTHER
Principal Investigators
-
Antonio Abbate, MD, PhD · Virginia Commonwealth University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-01
- Primary Completion
- 2018-12-23
- Completion
- 2018-12-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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