Trial Outcomes & Findings for Evolocumab in Patients With Acute MI (NCT NCT04082442)
NCT ID: NCT04082442
Last Updated: 2025-10-23
Results Overview
The difference, in the percent change in LDL-cholesterol (mg/dL), from baseline to the 25-30 day values.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Baseline, 25-30 days
Results posted on
2025-10-23
Participant Flow
Participant milestones
| Measure |
Evolocumab
420 mg evolocumab administered subcutaneously using an autoinjector/pen in ACS patients.
Evolocumab: 420 mg evolocumab.
|
Placebo
Placebo administered subcutaneously using an autoinjector/pen in ACS patients .
Placebos: Matching placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
23
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evolocumab in Patients With Acute MI
Baseline characteristics by cohort
| Measure |
Evolocumab
n=50 Participants
420 mg evolocumab administered subcutaneously using an autoinjector/pen in ACS patients.
Evolocumab: 420 mg evolocumab.
|
Placebo
n=50 Participants
Placebo administered subcutaneously using an autoinjector/pen in ACS patients .
Placebos: Matching placebo.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 11 • n=5 Participants
|
61 years
STANDARD_DEVIATION 11 • n=7 Participants
|
61.94 years
STANDARD_DEVIATION 11.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 25-30 daysThe difference, in the percent change in LDL-cholesterol (mg/dL), from baseline to the 25-30 day values.
Outcome measures
| Measure |
Evolocumab
n=27 Participants
420 mg evolocumab administered subcutaneously using an autoinjector/pen in ACS patients.
Evolocumab: 420 mg evolocumab.
|
Placebo
n=29 Participants
Placebo administered subcutaneously using an autoinjector/pen in ACS patients .
Placebos: Matching placebo.
|
|---|---|---|
|
Change in LDL-Cholesterol
|
-70.59 percent change mg/dL
Interval -82.0 to -58.21
|
-44.78 percent change mg/dL
Interval -58.43 to -6.34
|
SECONDARY outcome
Timeframe: Baseline, 30 daysPopulation: participants who completed the follow-up scan at 30 days
The change between early infarction period and thirty day assessments of PET-FDG assessed myocardial inflammation. A higher SUV value= worse inflammation. There are no standard values for this, since this study is the first to describe this in this patient population.
Outcome measures
| Measure |
Evolocumab
n=11 Participants
420 mg evolocumab administered subcutaneously using an autoinjector/pen in ACS patients.
Evolocumab: 420 mg evolocumab.
|
Placebo
n=14 Participants
Placebo administered subcutaneously using an autoinjector/pen in ACS patients .
Placebos: Matching placebo.
|
|---|---|---|
|
FDG-PET Imaging Analysis of Inflammation as Mean Standardized Uptake Value (SUV)
|
-26.21 Standardized Uptake Value (SUV)
Standard Deviation 22.61
|
-14.52 Standardized Uptake Value (SUV)
Standard Deviation 36.92
|
Adverse Events
Evolocumab
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Evolocumab
n=50 participants at risk
420 mg evolocumab administered subcutaneously using an autoinjector/pen in ACS patients.
Evolocumab: 420 mg evolocumab.
|
Placebo
n=50 participants at risk
Placebo administered subcutaneously using an autoinjector/pen in ACS patients .
Placebos: Matching placebo.
|
|---|---|---|
|
Cardiac disorders
Angina
|
4.0%
2/50 • From baseline up to 30 days
|
4.0%
2/50 • From baseline up to 30 days
|
|
Cardiac disorders
Heart Failure
|
0.00%
0/50 • From baseline up to 30 days
|
2.0%
1/50 • From baseline up to 30 days
|
|
Cardiac disorders
PEA Arrest
|
2.0%
1/50 • From baseline up to 30 days
|
0.00%
0/50 • From baseline up to 30 days
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/50 • From baseline up to 30 days
|
2.0%
1/50 • From baseline up to 30 days
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/50 • From baseline up to 30 days
|
2.0%
1/50 • From baseline up to 30 days
|
Other adverse events
| Measure |
Evolocumab
n=50 participants at risk
420 mg evolocumab administered subcutaneously using an autoinjector/pen in ACS patients.
Evolocumab: 420 mg evolocumab.
|
Placebo
n=50 participants at risk
Placebo administered subcutaneously using an autoinjector/pen in ACS patients .
Placebos: Matching placebo.
|
|---|---|---|
|
Cardiac disorders
Episode of NSVT
|
2.0%
1/50 • From baseline up to 30 days
|
0.00%
0/50 • From baseline up to 30 days
|
|
Cardiac disorders
Atrial fibrilation
|
0.00%
0/50 • From baseline up to 30 days
|
2.0%
1/50 • From baseline up to 30 days
|
|
Cardiac disorders
Recurrent Ischemia
|
2.0%
1/50 • From baseline up to 30 days
|
0.00%
0/50 • From baseline up to 30 days
|
|
Gastrointestinal disorders
Dyspepsia and constipation
|
0.00%
0/50 • From baseline up to 30 days
|
2.0%
1/50 • From baseline up to 30 days
|
|
Vascular disorders
Hypotension
|
2.0%
1/50 • From baseline up to 30 days
|
0.00%
0/50 • From baseline up to 30 days
|
|
Immune system disorders
Food related allergy
|
2.0%
1/50 • From baseline up to 30 days
|
0.00%
0/50 • From baseline up to 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place