Trial · NCT03515304

Evolocumab in Acute Coronary Syndrome

NCT03515304, Phase 2, Completed, Johns Hopkins University; results first posted 2025-11-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evolocumab in Acute Coronary Syndrome. Trials, record NCT03515304. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03515304

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evolocumab in Acute Coronary Syndrome
NCT number: NCT03515304
Status: Completed
Phases: Phase 2
Enrollment: 60 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Acute Coronary Syndrome
Interventions: Evolocumab, Placebo
First posted: 2018-05-03
Last updated: 2026-05-01
Results first posted: 2025-11-24

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change in LDL-Cholesterol	Baseline to 30 days
Primary	Change From Baseline in Target to Background Ratio Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Scans	Baseline to 30 days	PET Imaging for Inflammation: Change from baseline in target to background ratio Fluorodeoxyglucose (FDG) PET scans in the myocardium.
Secondary	Left Ventricular Volume as Assessed by Echocardiography	Baseline, day 30 and 6 months	Evaluation of left ventricular volume (ml) by echocardiography
Secondary	Ejection Fraction as Assessed by Echocardiography	Baseline, day 30 and 6 months	Evaluation of ejection fraction (%) by echocardiography
Secondary	Plasma Proprotein Convertase Subtilisin Kexin-9 (PCSK9) Levels (ng/ml)	Baseline, day 30 and 6 months	Change from baseline in PCSK9 serum levels
Secondary	PET-FDG Assessed Vascular Inflammation as Assessed by Standardized Uptake Value (SUV)	Baseline to day 30	Target artery to background ratio endpoint (standardized uptake value) for left carotid artery
Secondary	High Sensitivity C-reactive Protein (Hs-CRP) Serum Levels	Baseline, day 30 and 6 months	hs-CRP serum levels (mg/L)
Secondary	Change in Serum Levels of Interleukin 6	Baseline, day 30 and 6 months	Change in baseline in serum levels of Interleukin 6 (pg/mL)
Secondary	Serum Levels of Interleukin 10	Baseline, day 30 and 6 months	Serum levels of Interleukin 10 (pg/mL)

Source ClinicalTrials.gov

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change in LDL-Cholesterol	Baseline to 30 days	Participants with data collected	percent change	MEDIAN
PRIMARY	Change From Baseline in Target to Background Ratio Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Scans	Baseline to 30 days	Participants with PET data collected and adequate image quality for analysis	ratio	MEAN
SECONDARY	Change in Left Ventricular Volume as Assessed by Echocardiography	Baseline, day 30 and 6 months
SECONDARY	Change in Ejection Fraction as Assessed by Echocardiography	Baseline, day 30 and 6 months
SECONDARY	Change in Plasma Proprotein Convertase Subtilisin Kexin-9 (PCSK9) Levels (ng/ml)	Baseline, day 30 and 6 months
SECONDARY	Change in Plasma Soluble Lectin-like Oxidized Low-density Lipoprotein Receptor-1 (LOX-1)	Baseline, day 30 and 6 months
SECONDARY	PET-FDG Assessed Vascular Inflammation as Assessed by Standardized Uptake Value (SUV)	Baseline to day 30	Participants with PET data collected and adequate image quality for analysis	SUV	MEAN
SECONDARY	Change in New York Heart Association (NYHA) Class	Baseline, day 30 and 6 months
SECONDARY	Change in High Sensitivity C-reactive Protein (Hs-CRP) Serum Levels	Baseline, day 30 and 6 months
SECONDARY	Change in Tumor Necrosis Factor (TNF)-Alpha Serum Levels	Baseline, day 30 and 6 months

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Change in LDL-Cholesterol	Evolocumab	-68.78	Inter-Quartile Range -76.24 to -46.82	percent change
Percent Change in LDL-Cholesterol	Placebo	-27.58	Inter-Quartile Range -46.46 to 1.38	percent change
Change From Baseline in Target to Background Ratio Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Scans	Evolocumab	-26.7	Standard Deviation 20.4	ratio
Change From Baseline in Target to Background Ratio Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Scans	Placebo	-10.4	Standard Deviation 36.2	ratio
PET-FDG Assessed Vascular Inflammation as Assessed by Standardized Uptake Value (SUV)	Evolocumab	3.134705882	Standard Deviation 8.448074995	SUV
PET-FDG Assessed Vascular Inflammation as Assessed by Standardized Uptake Value (SUV)	Placebo	3.708333333	Standard Deviation 10.05850912	SUV

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Evolocumab	30
Overall Study	STARTED	Placebo	30
Overall Study	COMPLETED	Evolocumab	30
Overall Study	COMPLETED	Placebo	27
Overall Study	NOT COMPLETED	Evolocumab	0
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Angina	Cardiac disorders	Evolocumab	2	30	2
other	Angina	Cardiac disorders	Placebo	2	30	2
other	Pre-syncope	Nervous system disorders	Evolocumab	1	30	1
other	Pre-syncope	Nervous system disorders	Placebo	0	30	0
other	Ecchymosis injection site	Skin and subcutaneous tissue disorders	Evolocumab	3	30	3
other	Ecchymosis injection site	Skin and subcutaneous tissue disorders	Placebo	1	30	1
other	Diarrhea	Gastrointestinal disorders	Evolocumab	1	30	1
other	Diarrhea	Gastrointestinal disorders	Placebo	1	30	1
other	Post-infarction pericarditis	Cardiac disorders	Evolocumab	1	30	1
other	Post-infarction pericarditis	Cardiac disorders	Placebo	0	30	0

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Evolocumab	0	30
Total, all-cause mortality	Placebo	0	30
Total, other adverse events	Evolocumab	13	30
Total, other adverse events	Placebo	6	30
Total, serious adverse events	Evolocumab	2	30
Total, serious adverse events	Placebo	6	30

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35314069	DERIVED	PubMed
40780143	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Evolocumab vs Placebo: deaths from any cause	Trial comparisons
Evolocumab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03515304

GET https://conductscience.org/api/trials/v1/NCT03515304/events?page=2

API reference For AI assistants