Trial Outcomes & Findings for Anakinra to Prevent Adverse Post-infarction Remodeling (2) (NCT NCT01175018)
NCT ID: NCT01175018
Last Updated: 2016-05-23
Results Overview
Change in n left ventricular end-systolic volume indices from baseline to follow up exam at cardiac magnetic resonance imaging comparing anakinra- and placebo-treated patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
10-14 weeks minus baseline
Results posted on
2016-05-23
Participant Flow
Participant milestones
| Measure |
Anakinra
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
0.67 ml of sodium chloride (NaCl) 0.9% solution
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Anakinra
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
0.67 ml of sodium chloride (NaCl) 0.9% solution
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
Baseline Characteristics
Anakinra to Prevent Adverse Post-infarction Remodeling (2)
Baseline characteristics by cohort
| Measure |
Anakinra
n=15 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=15 Participants
0.67 ml of NaCl 0.9% solution
|
Total
n=30 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
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 12 • n=5 Participants
|
58 years
STANDARD_DEVIATION 12 • n=7 Participants
|
59 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10-14 weeks minus baselinePopulation: Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.
Change in n left ventricular end-systolic volume indices from baseline to follow up exam at cardiac magnetic resonance imaging comparing anakinra- and placebo-treated patients.
Outcome measures
| Measure |
Anakinra
n=11 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=14 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices
|
1.5 mL/m2
Interval -3.0 to 3.0
|
1.0 mL/m2
Interval -4.5 to 6.0
|
SECONDARY outcome
Timeframe: 10-14 weeksPopulation: Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.
Outcome measures
| Measure |
Anakinra
n=11 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=14 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-diastolic Volume Indices From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging
|
3 mL/m2
Interval -3.0 to 10.0
|
-4 mL/m2
Interval -12.0 to 17.0
|
SECONDARY outcome
Timeframe: 10-14 weeksOutcome measures
| Measure |
Anakinra
n=11 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=14 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >5%)
|
45 % of participants
|
43 % of participants
|
SECONDARY outcome
Timeframe: 10-14 weeksOutcome measures
| Measure |
Anakinra
n=4 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=6 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Median Difference Between the 2 Arms in the Peak Oxygen Consumption (VO2) at 10-14 Weeks
|
-1 ml*kg^-1*min^-1
Interval -13.0 to 1.0
|
2.5 ml*kg^-1*min^-1
Interval -1.0 to 7.0
|
SECONDARY outcome
Timeframe: 10-14 weeksDifference between the anakinra arm and the placebo arm in number of patients with a new diagnosis or admission to the hospital for heart failure
Outcome measures
| Measure |
Anakinra
n=15 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=15 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Incidence of Heart Failure
|
1 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 10-14 weeksOutcome measures
| Measure |
Anakinra
n=15 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=15 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Number of Adverse Events in Each Group
|
11 adverse events
|
20 adverse events
|
SECONDARY outcome
Timeframe: 10-14 weeksOutcome measures
| Measure |
Anakinra
n=11 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=14 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Difference Between the 2 Arm in the Interval Change in Right Ventricular Ejection Fraction (RVEF)
|
5 % (absolute change)
Interval -2.0 to 11.0
|
4 % (absolute change)
Interval -4.0 to 10.0
|
SECONDARY outcome
Timeframe: 10-14 weeksOutcome measures
| Measure |
Anakinra
n=11 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=14 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging
|
2 % (absolute change)
Interval -2.0 to 10.0
|
-2 % (absolute change)
Interval -5.0 to 5.0
|
SECONDARY outcome
Timeframe: 10-14 weeksOutcome measures
| Measure |
Anakinra
n=4 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=6 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Median Difference Between the 2 Arms in the Ratio of Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) at 10-14 Weeks
|
-1 (no units; ratio of values)
Interval -17.0 to 2.0
|
-3 (no units; ratio of values)
Interval -6.0 to -1.0
|
SECONDARY outcome
Timeframe: 10-14 weeksOutcome measures
| Measure |
Anakinra
n=11 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=14 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >10%)
|
27 % of participants
|
36 % of participants
|
SECONDARY outcome
Timeframe: 10-14 weeksPopulation: Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.
Outcome measures
| Measure |
Anakinra
n=11 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=14 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >5%) Based Upon Cardiac Magnetic Resonance Imaging
|
55 % of participants
|
42 % of participants
|
SECONDARY outcome
Timeframe: 10-14 weeksOutcome measures
| Measure |
Anakinra
n=11 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=14 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >10%)
|
45 % of participants
|
29 % of participants
|
SECONDARY outcome
Timeframe: 10-14 weeksOutcome measures
| Measure |
Anakinra
n=11 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=14 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >5%
|
36 % of participants
|
36 % of participants
|
SECONDARY outcome
Timeframe: 10-14 weeksOutcome measures
| Measure |
Anakinra
n=11 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=14 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >10%
|
27 % of participants
|
0 % of participants
|
SECONDARY outcome
Timeframe: 10-14 weeksOutcome measures
| Measure |
Anakinra
n=15 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=15 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Number of Deaths in Each Group
|
0 deaths
|
1 deaths
|
SECONDARY outcome
Timeframe: 10-14 weeksOutcome measures
| Measure |
Anakinra
n=15 Participants
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=15 Participants
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Number of Adverse Events Requiring Withdrawal in Each Group
|
2 adverse events
|
2 adverse events
|
Adverse Events
Anakinra
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anakinra
n=15 participants at risk
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=15 participants at risk
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Cardiac disorders
Death
|
0.00%
0/15 • 12 weeks
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
New onset heart failure
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
26.7%
4/15 • Number of events 4 • 12 weeks
|
|
Infections and infestations
Serious infection
|
13.3%
2/15 • Number of events 2 • 12 weeks
|
13.3%
2/15 • Number of events 2 • 12 weeks
|
|
Cardiac disorders
Recurrent myocardial infarction or repeat percutaneous coronary intervention
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
Left ventricular thrombus
|
0.00%
0/15 • 12 weeks
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
Cardiac rupture
|
0.00%
0/15 • 12 weeks
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
Other adverse events
| Measure |
Anakinra
n=15 participants at risk
Anakinra 100 mg injectable subcutaneously daily
|
Placebo
n=15 participants at risk
0.67 ml of NaCl 0.9% solution
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding (not serious)
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
26.7%
4/15 • Number of events 4 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Injection site pain
|
20.0%
3/15 • Number of events 3 • 12 weeks
|
13.3%
2/15 • Number of events 2 • 12 weeks
|
|
Cardiac disorders
Presyncope
|
0.00%
0/15 • 12 weeks
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/15 • 12 weeks
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
Hyperkalemia
|
0.00%
0/15 • 12 weeks
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/15 • 12 weeks
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Infection (not serious)
|
13.3%
2/15 • Number of events 2 • 12 weeks
|
0.00%
0/15 • 12 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
1/15 • Number of events 1 • 12 weeks
|
0.00%
0/15 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place