Trial · NCT03570697

Imaging of Coronary Plaques in Participants Treated With Evolocumab

NCT03570697, Phase 3, Completed, Amgen; results first posted 2021-11-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Imaging of Coronary Plaques in Participants Treated With Evolocumab. Trials, record NCT03570697. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03570697

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Trial

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

Title: Imaging of Coronary Plaques in Participants Treated With Evolocumab
NCT number: NCT03570697
Status: Completed
Phases: Phase 3
Enrollment: 164 participants, actual
Lead sponsor: Amgen
Conditions: Coronary Artery Disease (CAD)
Interventions: Evolocumab, Placebo, Statin therapy
First posted: 2018-06-27
Last updated: 2022-05-03
Other registries' IDs: eudract:2017-003236-37
Results first posted: 2021-11-24

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Absolute Change From Baseline in Minimum FCT	Baseline, week 50	Absolute change from baseline in minimum FCT in a matched segment of artery as determined by OCT. Minimum FCT for a participant is defined as the minimum of all minimum FCT measurements within each individual frame across all frames of that participant. Higher value of FCT indicates a better situation.
Secondary	Percent Change From Baseline in Minimum FCT	Baseline, week 50	Percent change from baseline in minimum FCT in a matched segment of artery as determined by OCT. Minimum FCT for a participant is defined as the minimum of all minimum FCT measurements within each individual frame across all frames of that participant. Higher value of FCT indicates a better situation.
Secondary	Absolute Change From Baseline in Mean Minimum FCT	Baseline, week 50	Absolute change from baseline in mean minimum FCT for all images assessed in an individual participant as determined by OCT. Minimum FCT for a participant is defined as the minimum of all minimum FCT measurements within each individual frame across all frames of that participant. Higher value of FCT indicates a better situation.
Secondary	Absolute Change From Baseline in the Maximum Lipid Arc	Baseline, week 50	Absolute change from baseline in the maximum lipid arc in a matched segment of artery as determined by OCT. Lower value of lipid arc indicates a better situation.
Secondary	Absolute Change From Baseline in Minimum FCT in Lipid Rich Plaques	Baseline, week 50	Absolute change from baseline in minimum FCT in lipid rich plaques as determined by OCT. Lipid rich plaques are defined as minimum FCT less than 120 μm and lipid arc greater than 90° in at least 3 consecutive images as determined by OCT. Higher value of FCT indicates a better situation
Secondary	Absolute Change From Baseline in Maximum Lipid Arc in Lipid Rich Plaques	Baseline, week 50	Absolute change from baseline in maximum lipid arc in lipid rich plaques. Lipid rich plaques are defined as minimum FCT less than 120 μm and lipid arc greater than 90° in at least 3 consecutive images as determined by OCT. Lower value of lipid arc indicates a better situation.
Secondary	Absolute Change From Baseline in Lipid Core Length in Lipid Rich Plaques	Baseline, week 50	Absolute change from baseline in lipid core length in lipid rich plaques. Lipid rich plaques are defined as minimum FCT less than 120 μm and lipid arc greater than 90° in at least 3 consecutive images as determined by OCT. Lower value of lipid core length indicates a better situation.

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Absolute Change From Baseline in Minimum FCT	Baseline, week 50	Full Analysis Set: all participants who received at least 1 dose of study drug.	µm	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Minimum FCT	Baseline, week 50	Full Analysis Set: all participants who received at least 1 dose of study drug.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Absolute Change From Baseline in Mean Minimum FCT	Baseline, week 50	Full Analysis Set: all participants who received at least 1 dose of study drug.	µm	LEAST_SQUARES_MEAN
SECONDARY	Absolute Change From Baseline in the Maximum Lipid Arc	Baseline, week 50	Full Analysis Set: all participants who received at least 1 dose of study drug.	degrees	LEAST_SQUARES_MEAN
SECONDARY	Absolute Change From Baseline in Minimum FCT in Lipid Rich Plaques	Baseline, week 50	Full Analysis Set: all participants who received at least 1 dose of study drug.	μm	LEAST_SQUARES_MEAN
SECONDARY	Absolute Change From Baseline in Maximum Lipid Arc in Lipid Rich Plaques	Baseline, week 50	Full Analysis Set: all participants who received at least 1 dose of study drug.	degrees	LEAST_SQUARES_MEAN
SECONDARY	Absolute Change From Baseline in Lipid Core Length in Lipid Rich Plaques	Baseline, week 50	Full Analysis Set: all participants who received at least 1 dose of study drug.	mm	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Value	Spread	Units
Absolute Change From Baseline in Minimum FCT	Placebo	21.5	Standard Error 5.2	µm
Absolute Change From Baseline in Minimum FCT	Evolocumab	42.7	Standard Error 5.1	µm
Percent Change From Baseline in Minimum FCT	Placebo	44.30	Standard Error 11.76	percent change
Percent Change From Baseline in Minimum FCT	Evolocumab	81.76	Standard Error 10.94	percent change
Absolute Change From Baseline in Mean Minimum FCT	Placebo	29.78	Standard Error 6.88	µm
Absolute Change From Baseline in Mean Minimum FCT	Evolocumab	62.29	Standard Error 5.95	µm
Absolute Change From Baseline in the Maximum Lipid Arc	Placebo	-31.4	Standard Error 9.0	degrees
Absolute Change From Baseline in the Maximum Lipid Arc	Evolocumab	-57.5	Standard Error 7.4	degrees
Absolute Change From Baseline in Minimum FCT in Lipid Rich Plaques	Placebo	24.6	Standard Error 5.5	μm
Absolute Change From Baseline in Minimum FCT in Lipid Rich Plaques	Evolocumab	40.6	Standard Error 5.5	μm

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	82
Overall Study	STARTED	Evolocumab	82
Overall Study	Received at Least 1 Dose of Study Drug	Placebo	81
Overall Study	Received at Least 1 Dose of Study Drug	Evolocumab	80
Overall Study	COMPLETED	Placebo	76
Overall Study	COMPLETED	Evolocumab	79
Overall Study	NOT COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	Evolocumab	3

Source ClinicalTrials.gov

Adverse events102

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
other	Angina pectoris	Cardiac disorders	Placebo	7	81
other	Angina pectoris	Cardiac disorders	Evolocumab	4	80
other	Bradycardia	Cardiac disorders	Placebo	0	81
other	Bradycardia	Cardiac disorders	Evolocumab	2	80
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	1	81
other	Abdominal pain upper	Gastrointestinal disorders	Evolocumab	2	80
other	Diarrhoea	Gastrointestinal disorders	Placebo	4	81
other	Diarrhoea	Gastrointestinal disorders	Evolocumab	3	80
other	Fatigue	General disorders	Placebo	2	81
other	Fatigue	General disorders	Evolocumab	3	80

1 to 10 of 102Source ClinicalTrials.gov

See all 102 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	2	82
Total, all-cause mortality	Evolocumab	0	82
Total, other adverse events	Placebo	30	81
Total, other adverse events	Evolocumab	31	80
Total, serious adverse events	Placebo	16	81
Total, serious adverse events	Evolocumab	13	80

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33355725	BACKGROUND	PubMed
33708484	BACKGROUND	PubMed
35431172	DERIVED	PubMed
40020597	DERIVED	PubMed
40424182	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/NCT03570697

GET https://conductscience.org/api/trials/v1/NCT03570697/events?page=2

API reference For AI assistants