Trial Outcomes & Findings for Evolocumab in Acute Coronary Syndrome (NCT NCT03515304)
NCT ID: NCT03515304
Last Updated: 2025-11-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline to 30 days
Results posted on
2025-11-24
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
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=45 Participants
|
18 Participants
n=12929 Participants
|
37 Participants
n=6349 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=45 Participants
|
12 Participants
n=12929 Participants
|
23 Participants
n=6349 Participants
|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 13.9 • n=45 Participants
|
59.4 years
STANDARD_DEVIATION 14.2 • n=12929 Participants
|
60.1 years
STANDARD_DEVIATION 14.3 • n=6349 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=45 Participants
|
9 Participants
n=12929 Participants
|
25 Participants
n=6349 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=45 Participants
|
21 Participants
n=12929 Participants
|
35 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=45 Participants
|
8 Participants
n=12929 Participants
|
19 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=45 Participants
|
20 Participants
n=12929 Participants
|
36 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
4 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=45 Participants
|
30 Participants
n=12929 Participants
|
60 Participants
n=6349 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 monthsEvaluation of left ventricular volume (ml) by echocardiography
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, day 30 and 6 monthsEvaluation of ejection fraction (%) by echocardiography
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, day 30 and 6 monthsChange from baseline in PCSK9 serum levels
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, day 30 and 6 monthsChange from baseline in plasma soluble lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) (pg/ml)
Outcome measures
Outcome data not reported
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 monthsAssess NYHA class I-IV
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, day 30 and 6 monthsChange from baseline in hs-CRP serum levels (mg/L)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, day 30 and 6 monthsChange from baseline in TNF-alpha serum levels (pg/mL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, day 30 and 6 monthsChange from baseline in serum levels of Interleukin 1 (pg/mL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, day 30 and 6 monthsChange in baseline in serum levels of Interleukin 6 (pg/mL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, day 30 and 6 monthsChange in baseline in serum levels of Interleukin 10 (pg/mL)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 30 days, 6 monthsAssess Canadian Angina Classification, I-IV
Outcome measures
Outcome data not reported
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.
|
|---|---|---|
|
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
|
|
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
|
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