Trial Outcomes & Findings for Interleukin-1 (IL-1) Blockade in Acute Myocardial Infarction (VCU-ART3) (NCT NCT01950299)
NCT ID: NCT01950299
Last Updated: 2019-12-18
Results Overview
Comparison of area-under-the-curve for CRP up to day 14
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
99 participants
Primary outcome timeframe
14 days
Results posted on
2019-12-18
Participant Flow
Participant milestones
| Measure |
Anakinra (Standard Dose)
Anakinra 100 mg daily for 14 days
|
Anakinra (High Dose)
Anakinra 100 mg twice daily for 14 days
|
Placebo
Placebo for 14 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
31
|
35
|
|
Overall Study
COMPLETED
|
22
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Interleukin-1 (IL-1) Blockade in Acute Myocardial Infarction (VCU-ART3)
Baseline characteristics by cohort
| Measure |
Anakinra (Standard Dose)
n=33 Participants
Anakinra 100 mg daily for 14 days
|
Anakinra (High Dose)
n=31 Participants
Anakinra 100 mg twice daily for 14 days
|
Placebo
n=35 Participants
Placebo for 14 days
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Age, Continuous
|
53 years
n=5 Participants
|
55 years
n=7 Participants
|
56 years
n=5 Participants
|
55 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
31 participants
n=7 Participants
|
35 participants
n=5 Participants
|
99 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 14 daysComparison of area-under-the-curve for CRP up to day 14
Outcome measures
| Measure |
Anakinra (Standard Dose)
n=22 Participants
Anakinra 100 mg daily for 14 days
|
Anakinra (High Dose)
n=27 Participants
Anakinra 100 mg twice daily for 14 days
|
Placebo
n=28 Participants
Placebo for 14 days
|
|---|---|---|---|
|
Acute Phase Response (CRP Levels)
|
60.03 mg x day/L (milligram x day/liter)
Interval 23.5 to 138.72
|
86.35 mg x day/L (milligram x day/liter)
Interval 43.44 to 122.73
|
213.75 mg x day/L (milligram x day/liter)
Interval 131.36 to 394.2
|
SECONDARY outcome
Timeframe: 12 monthsPlacebo corrected interval change in left ventricular end-systolic volume over 12 months
Outcome measures
| Measure |
Anakinra (Standard Dose)
n=20 Participants
Anakinra 100 mg daily for 14 days
|
Anakinra (High Dose)
n=21 Participants
Anakinra 100 mg twice daily for 14 days
|
Placebo
n=25 Participants
Placebo for 14 days
|
|---|---|---|---|
|
Left Ventricular End-systolic Volume
|
0 mL (milliliters)
Interval -8.0 to 6.0
|
4 mL (milliliters)
Interval -14.0 to 11.0
|
-4 mL (milliliters)
Interval -15.0 to 1.0
|
SECONDARY outcome
Timeframe: 12 monthsPlacebo-corrected interval changes in left ventricular ejection fraction over 12 months
Outcome measures
| Measure |
Anakinra (Standard Dose)
n=20 Participants
Anakinra 100 mg daily for 14 days
|
Anakinra (High Dose)
n=21 Participants
Anakinra 100 mg twice daily for 14 days
|
Placebo
n=25 Participants
Placebo for 14 days
|
|---|---|---|---|
|
Left Ventricular Ejection Fraction
|
4 % (Left ventricular ejection fraction)
Interval -2.0 to 7.0
|
5 % (Left ventricular ejection fraction)
Interval -1.0 to 5.0
|
3 % (Left ventricular ejection fraction)
Interval -2.0 to 9.0
|
SECONDARY outcome
Timeframe: 12 monthsNew onset of heart failure symptoms (NYHA II-IV)
Outcome measures
| Measure |
Anakinra (Standard Dose)
n=33 Participants
Anakinra 100 mg daily for 14 days
|
Anakinra (High Dose)
n=31 Participants
Anakinra 100 mg twice daily for 14 days
|
Placebo
n=35 Participants
Placebo for 14 days
|
|---|---|---|---|
|
Heart Failure
|
3 Participants
|
3 Participants
|
9 Participants
|
Adverse Events
Anakinra (Standard Dose)
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Anakinra (High Dose)
Serious events: 7 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 8 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Anakinra (Standard Dose)
n=33 participants at risk
Anakinra 100 mg daily for 14 days
|
Anakinra (High Dose)
n=31 participants at risk
Anakinra 100 mg twice daily for 14 days
|
Placebo
n=35 participants at risk
Placebo for 14 days
|
|---|---|---|---|
|
Cardiac disorders
Death
|
0.00%
0/33 • 12 months
|
0.00%
0/31 • 12 months
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
Cardiac disorders
Heart Failure Hospitalization
|
0.00%
0/33 • 12 months
|
0.00%
0/31 • 12 months
|
8.6%
3/35 • Number of events 3 • 12 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
3.0%
1/33 • Number of events 1 • 12 months
|
3.2%
1/31 • Number of events 1 • 12 months
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
Infections and infestations
Infection
|
9.1%
3/33 • Number of events 3 • 12 months
|
19.4%
6/31 • Number of events 6 • 12 months
|
14.3%
5/35 • Number of events 5 • 12 months
|
|
Cardiac disorders
Unstable Angina
|
3.0%
1/33 • Number of events 1 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/35 • 12 months
|
|
Cardiac disorders
Revascularization
|
3.0%
1/33 • Number of events 1 • 12 months
|
0.00%
0/31 • 12 months
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
Cardiac disorders
Arrhythmia
|
3.0%
1/33 • Number of events 1 • 12 months
|
0.00%
0/31 • 12 months
|
2.9%
1/35 • Number of events 1 • 12 months
|
|
Nervous system disorders
Stroke/Transient Ischemic Attack
|
3.0%
1/33 • Number of events 1 • 12 months
|
0.00%
0/31 • 12 months
|
2.9%
1/35 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Anakinra (Standard Dose)
n=33 participants at risk
Anakinra 100 mg daily for 14 days
|
Anakinra (High Dose)
n=31 participants at risk
Anakinra 100 mg twice daily for 14 days
|
Placebo
n=35 participants at risk
Placebo for 14 days
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
18.2%
6/33 • Number of events 6 • 12 months
|
25.8%
8/31 • Number of events 8 • 12 months
|
2.9%
1/35 • Number of events 1 • 12 months
|
Additional Information
Antonio Abbate, MD, PhD
Virginia Commonwealth University
Phone: 804-828-0513
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place