Interleukin-1 (IL-1) Blockade in Acute Myocardial Infarction (VCU-ART3)
Information source: Virginia Commonwealth University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myocardial Infarction
Intervention: Anakinra 100 mg (Drug); Anakinra 100 mg (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Virginia Commonwealth University Official(s) and/or principal investigator(s): Antonio Abbate, MD, PhD, Principal Investigator, Affiliation: Virginia Commonwealth University
Overall contact: Antonio Abbate, MD, PhD, Phone: 804-828-0513, Email: aabbate@vcu.edu
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.
Clinical Details
Official title: Interleukin-1 Blockade With Anakinra in Patients With ST-segment Elevation Myocardial Infarction - the Virginia Commonwealth University Anakinra Remodeling Trial 3
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Acute phase response (CRP levels)
Secondary outcome: Left ventricular end-systolic volume indices changeLeft ventricular ejection fraction Heart Failure
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
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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)
- 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)
- 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)
Locations and Contacts
Antonio Abbate, MD, PhD, Phone: 804-828-0513, Email: aabbate@vcu.edu
Virginia Commonwealth University, Richmond, Virginia 23298, United States; Not yet recruiting Antonio Abbate, MD, PhD, Phone: 804-828-0513, Email: aabbate@vcu.edu Antonio Abbate, MD, PhD, Principal Investigator Benjamin Van Tassell, PharmD, Principal Investigator
Virginia Commonwealth University, Richmond, Virginia 23298, United States; Recruiting Antonio Abbate, MD, PhD, Phone: 804-828-0513, Email: aabbate@vcu.edu Antonio Abbate, MD, PhD, Principal Investigator
Additional Information
Starting date: July 2014
Last updated: June 5, 2015
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