Trial · NCT02729025
Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))
NCT02729025, Phase 3, Completed, Amgen; results first posted 2019-04-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a)). Trials, record NCT02729025. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02729025
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))
- NCT number
- NCT02729025
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 129 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Subjects With Hyperlipidemia, Dyslipidemia
- Interventions
- Evolocumab, Placebo
- First posted
- 2016-04-06
- Last updated
- 2022-09-23
- Other registries' IDs
- eudract:2015-003731-35
- Results first posted
- 2019-04-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Maximum Target-to-background Ratio in the Most Diseased Segment of the Index Vessel at Week 16 | Baseline and week 16 | Arterial inflammation was assessed using 18F-fluoro-deoxyglucose positron-emission tomography/computed tomography (18F-FDG PET/CT). Arterial 18F-FDG uptake is correlated with arterial macrophage content and predicts cardiovascular events. Images were analyzed by an experienced radiologist blinded to all patient characteristics. The maximum standardized uptake value was calculated as a time- and dose- corrected tissue radioactivity divided by body weight in the index and the target-to-background ratio (TBR) was calculated from the ratio of the standardized uptake value of the artery compared to mean background venous activity. The average maximum TBR for the most diseased segment (MDS) was calculated from a group of 3 contiguous slices (approximately 1.5 cm), centered on the slice with the highest maximum TBR in the index vessel. The index vessel was defined as the vessel (either the right or left carotid or aorta) with the highest mean TBR at baseline. |
| Secondary | Percent Change From Baseline in Lipoprotein(a) Concentration at Week 16 | Baseline and week 16 | |
| Secondary | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration at Week 16 | Baseline and week 16 | |
| Secondary | Percent Change From Baseline in Apolipoprotein B Concentration at Week 16 | Baseline and week 16 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Maximum Target-to-background Ratio in the Most Diseased Segment of the Index Vessel at Week 16 | Baseline and week 16 | Participants who received at least 1 dose of study drug with available data | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Lipoprotein(a) Concentration at Week 16 | Baseline and week 16 | Participants who received at least 1 dose of study drug with available data | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration at Week 16 | Baseline and week 16 | Participants who received at least 1 dose of study drug with available data | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B Concentration at Week 16 | Baseline and week 16 | Participants who received at least 1 dose of study drug with available data | percent change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Maximum Target-to-background Ratio in the Most Diseased Segment of the Index Vessel at Week 16 | Placebo | -5.31 | Standard Error 1.67 | percent change | |
| Percent Change From Baseline in Maximum Target-to-background Ratio in the Most Diseased Segment of the Index Vessel at Week 16 | Evolocumab 420 mg QM | -8.31 | Standard Error 1.67 | percent change | |
| Percent Change From Baseline in Lipoprotein(a) Concentration at Week 16 | Placebo | 1.06 | Standard Error 1.94 | percent change | |
| Percent Change From Baseline in Lipoprotein(a) Concentration at Week 16 | Evolocumab 420 mg QM | -12.83 | Standard Error 1.92 | percent change | |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration at Week 16 | Placebo | 1.64 | Standard Error 1.86 | percent change | |
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration at Week 16 | Evolocumab 420 mg QM | -59.02 | Standard Error 1.82 | percent change | |
| Percent Change From Baseline in Apolipoprotein B Concentration at Week 16 | Placebo | 3.29 | Standard Error 1.53 | percent change | |
| Percent Change From Baseline in Apolipoprotein B Concentration at Week 16 | Evolocumab 420 mg QM | -48.30 | Standard Error 1.51 | percent change |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 64 | |
| Overall Study | STARTED | Evolocumab 420 mg QM | 65 | |
| Overall Study | COMPLETED | Placebo | 64 | |
| Overall Study | COMPLETED | Evolocumab 420 mg QM | 64 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Evolocumab 420 mg QM | 1 |
Source ClinicalTrials.gov
Adverse events232
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 | Palpitations | Cardiac disorders | Placebo QM | 0 | 64 | |
| other | Palpitations | Cardiac disorders | Evolocumab 420 mg QM | 1 | 65 | |
| other | Dermoid cyst | Congenital, familial and genetic disorders | Placebo QM | 1 | 64 | |
| other | Dermoid cyst | Congenital, familial and genetic disorders | Evolocumab 420 mg QM | 0 | 65 | |
| other | Muscular dystrophy | Congenital, familial and genetic disorders | Placebo QM | 1 | 64 | |
| other | Muscular dystrophy | Congenital, familial and genetic disorders | Evolocumab 420 mg QM | 0 | 65 | |
| other | Excessive cerumen production | Ear and labyrinth disorders | Placebo QM | 1 | 64 | |
| other | Excessive cerumen production | Ear and labyrinth disorders | Evolocumab 420 mg QM | 0 | 65 | |
| other | Keratitis | Eye disorders | Placebo QM | 0 | 64 | |
| other | Keratitis | Eye disorders | Evolocumab 420 mg QM | 1 | 65 |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo QM | 0 | 64 |
| Total, all-cause mortality | Evolocumab 420 mg QM | 0 | 65 |
| Total, other adverse events | Placebo QM | 47 | 64 |
| Total, other adverse events | Evolocumab 420 mg QM | 49 | 65 |
| Total, serious adverse events | Placebo QM | 0 | 64 |
| Total, serious adverse events | Evolocumab 420 mg QM | 2 | 65 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 420 mg QM vs Placebo QM: deaths from any cause | Trial comparisons |
| Evolocumab 420 mg QM vs Placebo QM: 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.
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/NCT02729025
GET https://conductscience.org/api/trials/v1/NCT02729025/events?page=2