Trial Outcomes & Findings for Evolocumab in Acute Coronary Syndrome (NCT NCT03515304)
NCT ID: NCT03515304
Last Updated: 2026-05-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline to 30 days
Results posted on
2026-05-01
Participant Flow
Participant milestones
| Measure |
Evolocumab
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Evolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
Placebo
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Placebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Evolocumab
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Evolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
Placebo
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Placebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
Baseline Characteristics
Evolocumab in Acute Coronary Syndrome
Baseline characteristics by cohort
| Measure |
Placebo
n=30 Participants
placebo group
|
Evolocumab
n=30 Participants
evolocumab group
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=14 Participants
|
8 Participants
n=34 Participants
|
19 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=14 Participants
|
20 Participants
n=34 Participants
|
36 Participants
n=69 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=14 Participants
|
18 Participants
n=34 Participants
|
37 Participants
n=69 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=14 Participants
|
12 Participants
n=34 Participants
|
23 Participants
n=69 Participants
|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 13.9 • n=14 Participants
|
59.4 years
STANDARD_DEVIATION 14.2 • n=34 Participants
|
60.1 years
STANDARD_DEVIATION 14.3 • n=69 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=14 Participants
|
9 Participants
n=34 Participants
|
25 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=14 Participants
|
21 Participants
n=34 Participants
|
35 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
4 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=14 Participants
|
30 Participants
n=34 Participants
|
60 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: Baseline to 30 daysPopulation: Participants with data collected
Outcome measures
| Measure |
Evolocumab
n=30 Participants
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Evolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
Placebo
n=27 Participants
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Placebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
|---|---|---|
|
Percent Change in LDL-Cholesterol
|
-68.78 percent change
Interval -76.24 to -46.82
|
-27.58 percent change
Interval -46.46 to 1.38
|
PRIMARY outcome
Timeframe: Baseline to 30 daysPopulation: Participants with PET data collected and adequate image quality for analysis
PET Imaging for Inflammation: Change from baseline in target to background ratio Fluorodeoxyglucose (FDG) PET scans in the myocardium.
Outcome measures
| Measure |
Evolocumab
n=25 Participants
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Evolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
Placebo
n=30 Participants
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Placebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
|---|---|---|
|
Change From Baseline in Target to Background Ratio Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Scans
|
-26.7 ratio
Standard Deviation 20.4
|
-10.4 ratio
Standard Deviation 36.2
|
SECONDARY outcome
Timeframe: Baseline, day 30 and 6 monthsPopulation: Participants with data collected and evaluable images
Evaluation of left ventricular volume (ml) by echocardiography
Outcome measures
| Measure |
Evolocumab
n=26 Participants
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Evolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
Placebo
n=27 Participants
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Placebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
|---|---|---|
|
Left Ventricular Volume as Assessed by Echocardiography
Baseline Systolic Volume
|
67.80 ml
Standard Deviation 33.69
|
59.45 ml
Standard Deviation 30.64
|
|
Left Ventricular Volume as Assessed by Echocardiography
Day 30 Systolic Volume months
|
54.57 ml
Standard Deviation 23.05
|
55.63 ml
Standard Deviation 22.41
|
|
Left Ventricular Volume as Assessed by Echocardiography
6 month Systolic Volume
|
62.53 ml
Standard Deviation 35.78
|
51.12 ml
Standard Deviation 29.28
|
|
Left Ventricular Volume as Assessed by Echocardiography
Baseline Diastolic Volume
|
117.4 ml
Standard Deviation 33.63
|
112.0 ml
Standard Deviation 33.03
|
|
Left Ventricular Volume as Assessed by Echocardiography
Day 30 Diastolic Volume
|
110.6 ml
Standard Deviation 26.37
|
113.1 ml
Standard Deviation 32.48
|
|
Left Ventricular Volume as Assessed by Echocardiography
6 month Diastolic Volume
|
119.5 ml
Standard Deviation 35.05
|
105.9 ml
Standard Deviation 36.74
|
SECONDARY outcome
Timeframe: Baseline, day 30 and 6 monthsPopulation: Participants with data collected and evaluable images
Evaluation of ejection fraction (%) by echocardiography
Outcome measures
| Measure |
Evolocumab
n=26 Participants
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Evolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
Placebo
n=27 Participants
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Placebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
|---|---|---|
|
Ejection Fraction as Assessed by Echocardiography
Baseline Ejection Fraction
|
44.28 percent
Standard Deviation 12.70
|
49.04 percent
Standard Deviation 13.40
|
|
Ejection Fraction as Assessed by Echocardiography
Day 30 Ejection Fraction
|
51.35 percent
Standard Deviation 11.66
|
51.90 percent
Standard Deviation 8.90
|
|
Ejection Fraction as Assessed by Echocardiography
6 month Ejection Fraction
|
50.04 percent
Standard Deviation 13.28
|
54.39 percent
Standard Deviation 11.94
|
SECONDARY outcome
Timeframe: Baseline, day 30 and 6 monthsPopulation: Participants with data collected
Change from baseline in PCSK9 serum levels
Outcome measures
| Measure |
Evolocumab
n=27 Participants
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Evolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
Placebo
n=29 Participants
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Placebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
|---|---|---|
|
Plasma Proprotein Convertase Subtilisin Kexin-9 (PCSK9) Levels (ng/ml)
Baseline PCSK9 serum level
|
244.2 ng/ml
Standard Deviation 93.85
|
257.3 ng/ml
Standard Deviation 127.8
|
|
Plasma Proprotein Convertase Subtilisin Kexin-9 (PCSK9) Levels (ng/ml)
Day 30 PCSK9 serum level
|
NA ng/ml
Standard Deviation NA
assay interference with PCSK9 antibody all values were LLOQ
|
261.9 ng/ml
Standard Deviation 129.2
|
|
Plasma Proprotein Convertase Subtilisin Kexin-9 (PCSK9) Levels (ng/ml)
6 months PCSK9 serum level
|
215.4 ng/ml
Standard Deviation 81.76
|
264.5 ng/ml
Standard Deviation 110.0
|
SECONDARY outcome
Timeframe: Baseline to day 30Population: Participants with PET data collected and adequate image quality for analysis
Target artery to background ratio endpoint (standardized uptake value) for left carotid artery
Outcome measures
| Measure |
Evolocumab
n=20 Participants
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Evolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
Placebo
n=14 Participants
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Placebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
|---|---|---|
|
PET-FDG Assessed Vascular Inflammation as Assessed by Standardized Uptake Value (SUV)
|
3.134705882 SUV
Standard Deviation 8.448074995
|
3.708333333 SUV
Standard Deviation 10.05850912
|
SECONDARY outcome
Timeframe: Baseline, day 30 and 6 monthsPopulation: Participants with data collected
hs-CRP serum levels (mg/L)
Outcome measures
| Measure |
Evolocumab
n=28 Participants
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Evolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
Placebo
n=28 Participants
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Placebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
|---|---|---|
|
High Sensitivity C-reactive Protein (Hs-CRP) Serum Levels
Baseline hs-CRP
|
29.59 mg/L
Standard Deviation 40.41
|
35.48 mg/L
Standard Deviation 43.49
|
|
High Sensitivity C-reactive Protein (Hs-CRP) Serum Levels
Day 30 hs-CRP
|
15.18 mg/L
Standard Deviation 47.53
|
7.609 mg/L
Standard Deviation 14.71
|
|
High Sensitivity C-reactive Protein (Hs-CRP) Serum Levels
6 month hs-CRP
|
5.174 mg/L
Standard Deviation 6.582
|
3.121 mg/L
Standard Deviation 4.852
|
SECONDARY outcome
Timeframe: Baseline, day 30 and 6 monthsPopulation: Participants with data collected
Change in baseline in serum levels of Interleukin 6 (pg/mL)
Outcome measures
| Measure |
Evolocumab
n=27 Participants
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Evolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
Placebo
n=28 Participants
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Placebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
|---|---|---|
|
Change in Serum Levels of Interleukin 6
Day 30 Interleukin 6
|
8.310 pg/ml
Standard Deviation 15.06
|
5.962 pg/ml
Standard Deviation 12.32
|
|
Change in Serum Levels of Interleukin 6
6 month Interleukin 6
|
6.941 pg/ml
Standard Deviation 8.633
|
2.200 pg/ml
Standard Deviation 3.001
|
|
Change in Serum Levels of Interleukin 6
Baseline Interleukin 6
|
34.31 pg/ml
Standard Deviation 41.39
|
23.08 pg/ml
Standard Deviation 20.68
|
SECONDARY outcome
Timeframe: Baseline, day 30 and 6 monthsPopulation: Participants with data collected
Serum levels of Interleukin 10 (pg/mL)
Outcome measures
| Measure |
Evolocumab
n=27 Participants
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Evolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
Placebo
n=26 Participants
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Placebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
|---|---|---|
|
Serum Levels of Interleukin 10
Day 30 Interleukin 10
|
9.370 pg/ml
Standard Deviation 19.35
|
5.204 pg/ml
Standard Deviation 5.587
|
|
Serum Levels of Interleukin 10
6 month Interleukin 10
|
9.291 pg/ml
Standard Deviation 16.38
|
5.243 pg/ml
Standard Deviation 6.359
|
|
Serum Levels of Interleukin 10
Baseline Interleukin 10
|
10.61 pg/ml
Standard Deviation 11.77
|
7.948 pg/ml
Standard Deviation 9.279
|
Adverse Events
Evolocumab
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Evolocumab
n=30 participants at risk
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Evolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
Placebo
n=30 participants at risk
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Placebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury requiring intermittent hemodialysis
|
0.00%
0/30 • from enrollment through 30-day follow-up
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.00%
0/30 • from enrollment through 30-day follow-up
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
|
Cardiac disorders
Recurrent non-ST elevation myocardial infarction
|
0.00%
0/30 • from enrollment through 30-day follow-up
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
|
Cardiac disorders
Transient myocardial ischemia prompting hospitalization
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
0.00%
0/30 • from enrollment through 30-day follow-up
|
|
Vascular disorders
Hospitalization for planned vascular surgery
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
0.00%
0/30 • from enrollment through 30-day follow-up
|
|
Musculoskeletal and connective tissue disorders
Hospitalization for neck pain
|
0.00%
0/30 • from enrollment through 30-day follow-up
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
|
Nervous system disorders
Transient ischemic attack, slurred speech
|
0.00%
0/30 • from enrollment through 30-day follow-up
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/30 • from enrollment through 30-day follow-up
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
Other adverse events
| Measure |
Evolocumab
n=30 participants at risk
420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Evolocumab: 420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
Placebo
n=30 participants at risk
Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
Placebo: Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
|
|---|---|---|
|
Cardiac disorders
Angina
|
6.7%
2/30 • Number of events 2 • from enrollment through 30-day follow-up
|
6.7%
2/30 • Number of events 2 • from enrollment through 30-day follow-up
|
|
Nervous system disorders
Pre-syncope
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
0.00%
0/30 • from enrollment through 30-day follow-up
|
|
Skin and subcutaneous tissue disorders
Ecchymosis injection site
|
10.0%
3/30 • Number of events 3 • from enrollment through 30-day follow-up
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
|
Cardiac disorders
Post-infarction pericarditis
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
0.00%
0/30 • from enrollment through 30-day follow-up
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
0.00%
0/30 • from enrollment through 30-day follow-up
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • Number of events 2 • from enrollment through 30-day follow-up
|
0.00%
0/30 • from enrollment through 30-day follow-up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
6.7%
2/30 • Number of events 2 • from enrollment through 30-day follow-up
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
1/30 • Number of events 1 • from enrollment through 30-day follow-up
|
0.00%
0/30 • from enrollment through 30-day follow-up
|
Additional Information
Dr. Thorsten Leucker
Johns Hopkins University - Baltimore, MD
Phone: 4105020469
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place