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

Phase 2

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: Anakinra 100 mg; Drug: Placebo

• Registration Number: NCT01950299
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

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

Study Timeline

• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-20
• Study First Posted: 2013-09-25
• Study Start: 2014-07-01
• Primary Completion: 2018-12-23
• Study Completion: 2018-12-23
• Status Verified: 2019-12
• Results First Submitted: 2019-12-03
• Results First Submitted QC: 2019-12-03
• Last Update Submitted: 2019-12-03
• Results First Posted: 2019-12-18
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anakinra (standard dose)	Anakinra 100 mg	Anakinra 100 mg daily for 14 days
Anakinra (standard dose)	Placebo	Anakinra 100 mg daily for 14 days
Anakinra (high dose)	Anakinra 100 mg	Anakinra 100 mg twice daily for 14 days
Placebo	Placebo	Placebo for 14 days

Primary Outcome Measures

Name	Time	Method
Acute Phase Response (CRP Levels)	14 days	Comparison of area-under-the-curve for CRP up to day 14

Secondary Outcome Measures

Name	Time	Method
Left Ventricular Ejection Fraction	12 months	Placebo-corrected interval changes in left ventricular ejection fraction over 12 months
Left Ventricular End-systolic Volume	12 months	Placebo corrected interval change in left ventricular end-systolic volume over 12 months
Heart Failure	12 months	New onset of heart failure symptoms (NYHA II-IV)

Trial Locations

Locations (2)

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States