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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 change

Left 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

Page last updated: August 23, 2015

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