Trial · NCT01813422
GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
NCT01813422, Phase 3, Completed, Amgen; results first posted 2018-01-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound. Trials, record NCT01813422. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01813422
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
- NCT number
- NCT01813422
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 970 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Hypercholesterolemia
- Interventions
- Evolocumab, Placebo
- First posted
- 2013-03-19
- Last updated
- 2019-02-20
- Other registries' IDs
- eudract:2012-004208-37
- Results first posted
- 2018-01-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Percent Atheroma Volume at Week 78 | Baseline and week 78 | Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma. |
| Secondary | Change From Baseline in Total Atheroma Volume at Week 78 | Baseline and week 78 | Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants. |
| Secondary | Percentage of Participants With Regression in Percent Atheroma Volume | Baseline and week 78 | Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma. Regression in PAV was defined as any reduction from baseline in PAV. |
| Secondary | Percentage of Participants With Regression in Total Atheroma Volume | Baseline and week 78 | Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants. Regression in TAV was defined as any reduction from baseline in TAV. |
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 | Change From Baseline in Percent Atheroma Volume at Week 78 | Baseline and week 78 | Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set) | percent atheroma volume | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Atheroma Volume at Week 78 | Baseline and week 78 | Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set) | mm³ | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Regression in Percent Atheroma Volume | Baseline and week 78 | Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set) | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Regression in Total Atheroma Volume | Baseline and week 78 | Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set) | percentage of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Change From Baseline in Percent Atheroma Volume at Week 78 | Placebo | 0.053 | Standard Error 0.189 | percent atheroma volume | |
| Change From Baseline in Percent Atheroma Volume at Week 78 | Evolocumab | -0.955 | Standard Error 0.190 | percent atheroma volume | |
| Change From Baseline in Total Atheroma Volume at Week 78 | Placebo | -0.910 | Standard Error 1.214 | mm³ | |
| Change From Baseline in Total Atheroma Volume at Week 78 | Evolocumab | -5.799 | Standard Error 1.216 | mm³ | |
| Percentage of Participants With Regression in Percent Atheroma Volume | Placebo | 47.3 | 95% Confidence Interval 42.6 to 52.0 | percentage of participants | |
| Percentage of Participants With Regression in Percent Atheroma Volume | Evolocumab | 64.3 | 95% Confidence Interval 59.6 to 68.7 | percentage of participants | |
| Percentage of Participants With Regression in Total Atheroma Volume | Placebo | 48.9 | 95% Confidence Interval 44.2 to 53.7 | percentage of participants | |
| Percentage of Participants With Regression in Total Atheroma Volume | Evolocumab | 61.5 | 95% Confidence Interval 56.7 to 66.0 | percentage of participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 486 | |
| Overall Study | STARTED | Evolocumab | 484 | |
| Overall Study | Received Treatment | Placebo | 484 | |
| Overall Study | Received Treatment | Evolocumab | 484 | |
| Overall Study | COMPLETED | Placebo | 466 | |
| Overall Study | COMPLETED | Evolocumab | 468 | |
| Overall Study | NOT COMPLETED | Placebo | 20 | |
| Overall Study | NOT COMPLETED | Evolocumab | 16 |
Source ClinicalTrials.gov
Adverse events436
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 pectoris | Cardiac disorders | Placebo | 32 | 484 | |
| other | Angina pectoris | Cardiac disorders | Evolocumab | 21 | 484 | |
| other | Chest pain | General disorders | Placebo | 26 | 484 | |
| other | Chest pain | General disorders | Evolocumab | 33 | 484 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Placebo | 27 | 484 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Evolocumab | 34 | 484 | |
| other | Headache | Nervous system disorders | Placebo | 29 | 484 | |
| other | Headache | Nervous system disorders | Evolocumab | 19 | 484 | |
| other | Hypertension | Vascular disorders | Placebo | 34 | 484 | |
| other | Hypertension | Vascular disorders | Evolocumab | 29 | 484 |
1 to 10 of 436Source ClinicalTrials.gov
See all 436 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Evolocumab | ||
| Total, other adverse events | Placebo | 120 | 484 |
| Total, other adverse events | Evolocumab | 114 | 484 |
| Total, serious adverse events | Placebo | 142 | 484 |
| Total, serious adverse events | Evolocumab | 135 | 484 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Evolocumab vs Placebo: serious adverse events |
Source 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/NCT01813422
GET https://conductscience.org/api/trials/v1/NCT01813422/events?page=2