Trial Outcomes & Findings for A Study of Acute Myocardial Infarction Using FDY-5301 (NCT NCT03470441)
NCT ID: NCT03470441
Last Updated: 2021-12-14
Results Overview
Number of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
First 48 hours post-treatment
Results posted on
2021-12-14
Participant Flow
The first participant enrolled on October 27, 2017 in study centers in Poland, Hungary, UK, and the United States.
A total of 120 subjects were randomized 3:1 to receive one of three dosage amounts of study drug or placebo.
Participant milestones
| Measure |
Experimental FDY-5301 Low Dose
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
2.0 mg/kg FDY-5301
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
31
|
29
|
|
Overall Study
COMPLETED
|
28
|
26
|
29
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
2
|
4
|
Reasons for withdrawal
| Measure |
Experimental FDY-5301 Low Dose
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
2.0 mg/kg FDY-5301
|
Placebo
Placebo
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
1
|
3
|
Baseline Characteristics
A Study of Acute Myocardial Infarction Using FDY-5301
Baseline characteristics by cohort
| Measure |
Experimental FDY-5301 Low Dose
n=29 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=31 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=31 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=29 Participants
Placebo
|
Total
n=120 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
|
Ethnicity (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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
113 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
6 participants
n=4 Participants
|
30 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
2 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
15 participants
n=5 Participants
|
18 participants
n=4 Participants
|
64 participants
n=21 Participants
|
|
BMI
|
27.1 kg/m2
STANDARD_DEVIATION 4.17 • n=5 Participants
|
28 kg/m2
STANDARD_DEVIATION 4.29 • n=7 Participants
|
28.1 kg/m2
STANDARD_DEVIATION 4.88 • n=5 Participants
|
28.5 kg/m2
STANDARD_DEVIATION 4.43 • n=4 Participants
|
27.9 kg/m2
STANDARD_DEVIATION 4.43 • n=21 Participants
|
|
Height
|
173 cm
STANDARD_DEVIATION 7.8 • n=5 Participants
|
171 cm
STANDARD_DEVIATION 8.2 • n=7 Participants
|
170 cm
STANDARD_DEVIATION 10.7 • n=5 Participants
|
170 cm
STANDARD_DEVIATION 8.3 • n=4 Participants
|
171 cm
STANDARD_DEVIATION 8.8 • n=21 Participants
|
|
Weight
|
81.62 kg
STANDARD_DEVIATION 14.703 • n=5 Participants
|
81.76 kg
STANDARD_DEVIATION 13.453 • n=7 Participants
|
81.52 kg
STANDARD_DEVIATION 15.749 • n=5 Participants
|
82.23 kg
STANDARD_DEVIATION 15.162 • n=4 Participants
|
81.78 kg
STANDARD_DEVIATION 14.601 • n=21 Participants
|
PRIMARY outcome
Timeframe: First 48 hours post-treatmentNumber of patients experiencing clinically relevant arrhythmias during the first 48 hours post-treatment.
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=28 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=29 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=29 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=26 Participants
Placebo
|
|---|---|---|---|---|
|
Arrhythmias of Interest, 48 Hours (Overall)
Ventricular Fibrillation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Arrhythmias of Interest, 48 Hours (Overall)
Sustained Ventricular Tachycardia
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Arrhythmias of Interest, 48 Hours (Overall)
Non-Sustained Ventricular Tachycardia
|
1 participants
|
1 participants
|
7 participants
|
2 participants
|
|
Arrhythmias of Interest, 48 Hours (Overall)
High-Degree AV Block
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Arrhythmias of Interest, 48 Hours (Overall)
Atrial Fibrillation
|
0 participants
|
2 participants
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 48 hours post-treatmentIncidence rate of clinically relevant arrhythmias during the first 48 hours post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=28 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=29 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=29 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=26 Participants
Placebo
|
|---|---|---|---|---|
|
Arrhythmias of Interest Incidence Rate, 48 Hours (Overall)
Ventricular Fibrillation
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
|
Arrhythmias of Interest Incidence Rate, 48 Hours (Overall)
Sustained Ventricular Tachycardia
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
|
Arrhythmias of Interest Incidence Rate, 48 Hours (Overall)
Non-Sustained Ventricular Tachycardia
|
.0766 Percentage
|
.0797 Percentage
|
.548 Percentage
|
.168 Percentage
|
|
Arrhythmias of Interest Incidence Rate, 48 Hours (Overall)
High-Degree AV Block
|
0 Percentage
|
0 Percentage
|
.157 Percentage
|
0 Percentage
|
|
Arrhythmias of Interest Incidence Rate, 48 Hours (Overall)
Atrial Fibrillation
|
0 Percentage
|
.159 Percentage
|
.0783 Percentage
|
.0838 Percentage
|
PRIMARY outcome
Timeframe: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)Number of patients experiencing clinically relevant arrhythmias 48 hours to 14 days post-treatment.
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=28 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=28 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=28 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=25 Participants
Placebo
|
|---|---|---|---|---|
|
Arrhythmias of Interest, 14 Days (Overall)
Ventricular Fibrillation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Arrhythmias of Interest, 14 Days (Overall)
Sustained Ventricular Tachycardia
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Arrhythmias of Interest, 14 Days (Overall)
Non-Sustained Ventricular Tachycardia
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Arrhythmias of Interest, 14 Days (Overall)
High-Degree AV Block
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Arrhythmias of Interest, 14 Days (Overall)
Atrial Fibrillation
|
3 participants
|
2 participants
|
2 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 48 hours to 14 days Post Percutaneous Coronary Intervention (PCI)Incidence rate of clinically relevant arrhythmias 48 hours to 14 days post-treatment defined as the number of patients who experienced an arrhythmia divided by the total person-monitoring time within each treatment group
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=28 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=28 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=28 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=25 Participants
Placebo
|
|---|---|---|---|---|
|
Arrhythmias of Interest Incidence Rate, 14 Days (Overall)
Ventricular Fibrillation
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
|
Arrhythmias of Interest Incidence Rate, 14 Days (Overall)
Sustained Ventricular Tachycardia
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
|
Arrhythmias of Interest Incidence Rate, 14 Days (Overall)
Non-Sustained Ventricular Tachycardia
|
0 Percentage
|
0.0147 Percentage
|
0 Percentage
|
0 Percentage
|
|
Arrhythmias of Interest Incidence Rate, 14 Days (Overall)
High-Degree AV Block
|
0 Percentage
|
0 Percentage
|
0.0295 Percentage
|
0 Percentage
|
|
Arrhythmias of Interest Incidence Rate, 14 Days (Overall)
Atrial Fibrillation
|
0.0475 Percentage
|
0.0293 Percentage
|
0.0295 Percentage
|
0.0166 Percentage
|
SECONDARY outcome
Timeframe: 72 hours post-treatmentInfarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=22 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=18 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=20 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=20 Participants
Placebo
|
|---|---|---|---|---|
|
Infarct Size Relative to Ventricular Volume, 72 Hours (Overall)
|
19.1 INF/VV (%)
Interval 0.0 to 50.2
|
16.9 INF/VV (%)
Interval 0.0 to 51.3
|
19.6 INF/VV (%)
Interval 5.2 to 51.4
|
20.4 INF/VV (%)
Interval 0.0 to 60.3
|
SECONDARY outcome
Timeframe: 3 months post-treatmentInfarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=24 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=14 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=22 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=15 Participants
Placebo
|
|---|---|---|---|---|
|
Infarct Size Relative to Ventricular Volume, 3 Months (Overall)
|
11.7 INF/VV (%)
Interval 0.0 to 52.0
|
11.4 INF/VV (%)
Interval 0.0 to 50.7
|
8.5 INF/VV (%)
Interval 0.0 to 49.5
|
14.9 INF/VV (%)
Interval 0.0 to 48.4
|
SECONDARY outcome
Timeframe: 72 hours post-treatmentInfarct size relative to ventricular volume (INF/VV) at 72 hours post-treatment)
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=9 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=6 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=7 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=7 Participants
Placebo
|
|---|---|---|---|---|
|
Infarct Size Relative to Ventricular Volume, 72 Hours (Anterior Infarcts)
|
33 INF/VV (%)
Interval 0.0 to 39.9
|
15.8 INF/VV (%)
Interval 0.0 to 51.3
|
12.1 INF/VV (%)
Interval 9.8 to 45.8
|
26.7 INF/VV (%)
Interval 0.0 to 60.3
|
SECONDARY outcome
Timeframe: 3 months post-treatmentInfarct size relative to ventricular volume (INF/VV) at 3 months post-treatment)
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=11 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=6 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=7 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=6 Participants
Placebo
|
|---|---|---|---|---|
|
Infarct Size Relative to Ventricular Volume, 3 Months (Anterior Infarcts)
|
19.7 INF/VV (%)
Interval 0.0 to 52.0
|
10.4 INF/VV (%)
Interval 0.0 to 50.7
|
9.3 INF/VV (%)
Interval 0.0 to 34.4
|
22.8 INF/VV (%)
Interval 1.4 to 48.4
|
SECONDARY outcome
Timeframe: 72 hours post-treatmentLeft ventricular end systolic volume index (LVESVi) at 72 hours post-treatment
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=25 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=21 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=21 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=21 Participants
Placebo
|
|---|---|---|---|---|
|
Left Ventricular End Systolic Volume Index, 72 Hours (Overall)
|
40 mL/kg/M2
Interval 20.0 to 65.2
|
32 mL/kg/M2
Interval 15.0 to 72.0
|
32 mL/kg/M2
Interval 12.0 to 68.0
|
38 mL/kg/M2
Interval 18.0 to 53.0
|
SECONDARY outcome
Timeframe: 3 months post-treatmentLeft ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=24 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=16 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=23 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=17 Participants
Placebo
|
|---|---|---|---|---|
|
Left Ventricular End Systolic Volume Index, 3 Months (Overall)
|
29 mL/kg/M2
Interval 15.0 to 78.0
|
25.5 mL/kg/M2
Interval 7.0 to 100.0
|
27 mL/kg/M2
Interval 10.0 to 73.0
|
36 mL/kg/M2
Interval 14.0 to 67.0
|
SECONDARY outcome
Timeframe: 72 hours post-treatmentLeft ventricular end systolic volume index (LVESVi) at 72 Hours post-treatment
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=10 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=7 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=8 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=7 Participants
Placebo
|
|---|---|---|---|---|
|
Left Ventricular End Systolic Volume Index, 72 Hours (Anterior Infarcts)
|
45.5 mL/kg/M2
Interval 21.0 to 65.2
|
32 mL/kg/M2
Interval 15.0 to 48.0
|
31 mL/kg/M2
Interval 13.1 to 41.0
|
42 mL/kg/M2
Interval 18.0 to 53.0
|
SECONDARY outcome
Timeframe: 3 months post-treatmentLeft ventricular end systolic volume index (LVESVi) at 3 Months post-treatment
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=11 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=6 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=8 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=7 Participants
Placebo
|
|---|---|---|---|---|
|
Left Ventricular End Systolic Volume Index, 3 Months (Anterior Infarcts)
|
37 mL/kg/M2
Interval 16.0 to 68.0
|
28 mL/kg/M2
Interval 7.0 to 43.0
|
23.5 mL/kg/M2
Interval 14.0 to 40.0
|
36 mL/kg/M2
Interval 19.0 to 67.0
|
SECONDARY outcome
Timeframe: 72 hours post-treatmentLeft ventricular ejection fraction at 72 hours post-treatment
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=25 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=21 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=21 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=21 Participants
Placebo
|
|---|---|---|---|---|
|
Left Ventricular Ejection Fraction, 72 Hours (Overall)
|
51.4 Percentage
Interval 31.2 to 69.5
|
51.7 Percentage
Interval 33.8 to 78.6
|
54.5 Percentage
Interval 35.9 to 75.1
|
48.7 Percentage
Interval 35.2 to 73.5
|
SECONDARY outcome
Timeframe: 3 months post-treatmentLeft Ventricular Ejection Fraction at 3 Months (Overall)
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=24 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=16 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=23 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=17 Participants
Placebo
|
|---|---|---|---|---|
|
Left Ventricular Ejection Fraction, 3 Months (Overall)
|
59.5 Percentage
Interval 29.0 to 72.4
|
58.9 Percentage
Interval 25.0 to 87.5
|
63.2 Percentage
Interval 36.8 to 72.1
|
53.9 Percentage
Interval 39.1 to 76.9
|
SECONDARY outcome
Timeframe: 72 hours post-treatmentLeft ventricular ejection fraction at 72 hours post-treatment
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=10 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=7 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=8 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=7 Participants
Placebo
|
|---|---|---|---|---|
|
Left Ventricular Ejection Fraction, 72 Hours (Anterior Infarcts)
|
48 Percentage
Interval 34.4 to 69.5
|
51.7 Percentage
Interval 33.8 to 78.6
|
57.3 Percentage
Interval 35.9 to 75.1
|
43.2 Percentage
Interval 35.2 to 73.5
|
SECONDARY outcome
Timeframe: 3 months post-treatmentLeft Ventricular Ejection Fraction at 3 Months (Anterior Infarcts)
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=11 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=6 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=8 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=7 Participants
Placebo
|
|---|---|---|---|---|
|
Left Ventricular Ejection Fraction, 3 Months (Anterior Infarcts)
|
55.7 Percentage
Interval 34.9 to 72.4
|
57.2 Percentage
Interval 45.2 to 87.5
|
67.6 Percentage
Interval 48.0 to 72.1
|
50.4 Percentage
Interval 41.2 to 76.9
|
SECONDARY outcome
Timeframe: 48 hours post-treatmentArea under the curve of serum troponins measured over 48 hours post-treatment
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=25 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=25 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=24 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|---|---|
|
Serum Troponin Concentrations, 48 Hours (Overall)
|
90.5 AUC4-48 µg/L
Interval -19.3 to 383.0
|
98.1 AUC4-48 µg/L
Interval 0.0274 to 538.0
|
108 AUC4-48 µg/L
Interval 32.8 to 591.0
|
112 AUC4-48 µg/L
Interval 4.5 to 752.0
|
SECONDARY outcome
Timeframe: 48 hours post-treatmentArea under the curve of serum troponins measured over 48 hours post-treatment
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=12 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=9 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=9 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=8 Participants
Placebo
|
|---|---|---|---|---|
|
Serum Troponin Concentrations, 48 Hours (Anterior Infarcts)
|
123 AUC4-48 µg/L
Interval -19.3 to 3361.0
|
55 AUC4-48 µg/L
Interval 0.0274 to 538.0
|
111 AUC4-48 µg/L
Interval 32.8 to 591.0
|
83.8 AUC4-48 µg/L
Interval 42.5 to 752.0
|
SECONDARY outcome
Timeframe: 4 hours post-doseProportion of patients with ST-segment resolution at 4 hours post-dose
Outcome measures
| Measure |
Experimental FDY-5301 Low Dose
n=25 Participants
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=25 Participants
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=21 Participants
2.0 mg/kg FDY-5301
|
Placebo
n=19 Participants
Placebo
|
|---|---|---|---|---|
|
ST-segment Resolution
|
48.0 percentage
|
68.0 percentage
|
52.4 percentage
|
47.4 percentage
|
Adverse Events
Experimental FDY-5301 Low Dose
Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths
Experimental FDY-5301 Intermediate Dose
Serious events: 7 serious events
Other events: 4 other events
Deaths: 1 deaths
Experimental FDY-5301 High Dose
Serious events: 4 serious events
Other events: 9 other events
Deaths: 1 deaths
Placebo
Serious events: 8 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Experimental FDY-5301 Low Dose
n=29 participants at risk
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=31 participants at risk
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=31 participants at risk
2.0 mg/kg FDY-5301
|
Placebo
n=29 participants at risk
Placebo
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/29 • Day 1 to 3 months
|
3.2%
1/31 • Number of events 1 • Day 1 to 3 months
|
6.5%
2/31 • Number of events 2 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/29 • Day 1 to 3 months
|
6.5%
2/31 • Number of events 2 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/29 • Day 1 to 3 months
|
3.2%
1/31 • Number of events 1 • Day 1 to 3 months
|
3.2%
1/31 • Number of events 1 • Day 1 to 3 months
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
|
Cardiac disorders
Atrial fibrillation
|
6.9%
2/29 • Number of events 2 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/29 • Day 1 to 3 months
|
3.2%
1/31 • Number of events 2 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Cardiac disorders
Coronary artery disease
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
3.2%
1/31 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Cardiac disorders
Acute myocardial infarction
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/29 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Cardiac disorders
Coronary artery dissection
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Cardiac disorders
Coronary artery perforation
|
0.00%
0/29 • Day 1 to 3 months
|
3.2%
1/31 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/29 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
|
General disorders
Chest pain
|
0.00%
0/29 • Day 1 to 3 months
|
6.5%
2/31 • Number of events 2 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
General disorders
Vascular stent thrombosis
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/29 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/29 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
|
Infections and infestations
Peritonitis
|
0.00%
0/29 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29 • Day 1 to 3 months
|
3.2%
1/31 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Gastrointestinal disorders
Colitis
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Gastrointestinal disorders
Gastroduodenitis
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/29 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/29 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/29 • Day 1 to 3 months
|
3.2%
1/31 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Investigations
Liver function test abnormal
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/29 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
|
Nervous system disorders
Ischaemic stroke
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Psychiatric disorders
Delirium
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/29 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
3.2%
1/31 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Vascular disorders
Haematoma
|
0.00%
0/29 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
Other adverse events
| Measure |
Experimental FDY-5301 Low Dose
n=29 participants at risk
0.5 mg/kg FDY-5301
|
Experimental FDY-5301 Intermediate Dose
n=31 participants at risk
1.0 mg/kg FDY-5301
|
Experimental FDY-5301 High Dose
n=31 participants at risk
2.0 mg/kg FDY-5301
|
Placebo
n=29 participants at risk
Placebo
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/29 • Day 1 to 3 months
|
6.5%
2/31 • Number of events 3 • Day 1 to 3 months
|
6.5%
2/31 • Number of events 2 • Day 1 to 3 months
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/29 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
6.9%
2/29 • Number of events 2 • Day 1 to 3 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/29 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
6.9%
2/29 • Number of events 2 • Day 1 to 3 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/29 • Day 1 to 3 months
|
6.5%
2/31 • Number of events 2 • Day 1 to 3 months
|
9.7%
3/31 • Number of events 3 • Day 1 to 3 months
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
|
Cardiac disorders
Cardiac failure
|
6.9%
2/29 • Number of events 2 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
3.2%
1/31 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
10.3%
3/29 • Number of events 3 • Day 1 to 3 months
|
|
Gastrointestinal disorders
Constipation
|
6.9%
2/29 • Number of events 2 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
General disorders
Chest pain
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
12.9%
4/31 • Number of events 4 • Day 1 to 3 months
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
|
Nervous system disorders
Dizziness
|
3.4%
1/29 • Number of events 1 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
6.9%
2/29 • Number of events 2 • Day 1 to 3 months
|
|
Nervous system disorders
Headache
|
0.00%
0/29 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
10.3%
3/29 • Number of events 3 • Day 1 to 3 months
|
|
Vascular disorders
Haematoma
|
6.9%
2/29 • Number of events 2 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/29 • Day 1 to 3 months
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/29 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
6.9%
2/29 • Number of events 2 • Day 1 to 3 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/29 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
0.00%
0/31 • Day 1 to 3 months
|
6.9%
2/29 • Number of events 2 • Day 1 to 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee We have multiple agreements (through our CRO) with multiple PIs in various countries. The most restrictive of those agreements prohibits the PI from publicly disclosing any study results without our (or our CRO's) prior written permission to do so.
- Publication restrictions are in place
Restriction type: OTHER