Interleukin-1 (IL-1) Blockade in Acute Myocardial Infarction (VCU-ART3) (VCU-ART3)
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ClinicalTrials.gov Identifier: NCT01950299 |
Recruitment Status
:
Active, not recruiting
First Posted
: September 25, 2013
Last Update Posted
: March 15, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myocardial Infarction | Drug: Anakinra 100 mg Drug: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 91 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Actual Study Start Date : | July 1, 2014 |
Actual Primary Completion Date : | January 1, 2018 |
Estimated Study Completion Date : | December 28, 2018 |

Arm | Intervention/treatment |
---|---|
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
|
- Acute phase response (CRP levels) [ Time Frame: 14 days ]Placebo corrected difference in the area-under-the-curve for CRP up to day 14
- Left ventricular end-systolic volume indices change [ Time Frame: 12 months ]Placebo corrected interval change in left ventricular end-systolic volume indices over 12 months
- Left ventricular ejection fraction [ Time Frame: 12 months ]Placebo-corrected interval changes in left ventricular ejection fraction over 12 months
- Heart Failure [ Time Frame: 12 months ]New onset of heart failure symptoms (NYHA II-IV)

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Ages Eligible for Study: | 21 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
In order to be eligible for this study, patients must meet ALL the 3 Inclusion criteria and NONE of the Exclusion criteria.
- 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
- Planned or completed coronary angiogram for potential intervention
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950299
United States, District of Columbia | |
Washington Hospital Center | |
Washington, District of Columbia, United States, 20010 | |
United States, Virginia | |
Virginia Commonwealth University | |
Richmond, Virginia, United States, 23298 |
Principal Investigator: | Antonio Abbate, MD, PhD | Virginia Commonwealth University |
Responsible Party: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT01950299 History of Changes |
Other Study ID Numbers: |
HM20000024 1R34HL121402-01 ( U.S. NIH Grant/Contract ) |
First Posted: | September 25, 2013 Key Record Dates |
Last Update Posted: | March 15, 2018 |
Last Verified: | March 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Infarction Myocardial Infarction ST Elevation Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Interleukin 1 Receptor Antagonist Protein Antirheumatic Agents |