Trial · NCT01764633
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
NCT01764633, Phase 3, Completed, Amgen; results first posted 2018-02-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk. Trials, record NCT01764633. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01764633
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
- NCT number
- NCT01764633
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 27,564 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Dyslipidemia
- Interventions
- Evolocumab, Placebo
- First posted
- 2013-01-09
- Last updated
- 2024-05-28
- Other registries' IDs
- eudract:2012-001398-97
- Results first posted
- 2018-02-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All deaths and potential endpoint events were adjudicated by an independent external Clinical Events Committee (CEC) led by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date. |
| Secondary | Time to Cardiovascular Death, Myocardial Infarction, or Stroke | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to cardiovascular death, myocardial infarction, or stroke was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date. |
| Secondary | Time to Cardiovascular Death | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Cardiovascular death includes death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes. Time to cardiovascular death was defined as the time from randomization to the date of cardiovascular death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date. |
| Secondary | Time to All Cause Death | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | Time to all-cause death was defined as the time from randomization to the date of death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date. |
| Secondary | Time to First Myocardial Infarction | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". The diagnosis of myocardial infarction required the combination of: * Evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and * Supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery Imaging. Time to first myocardial infarction was defined as the time from randomization to the date of the first MI and was analyzed using Kaplan-Meier survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date. |
| Secondary | Time to First Stroke | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Time to first stroke was defined as the time from randomization to the date of the stroke and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date. |
| Secondary | Time to First Coronary Revascularization | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the "Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction". Time to first coronary revascularization was defined as the time from randomization to the date of the coronary revascularization and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date. |
| Secondary | Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions. HF hospitalization was defined as an event that met all of the following criteria: 1. Admitted to hospital with a primary diagnosis of HF 2. In hospital for at least 24 hours 3. Documented new or worsening symptoms due to HF, including at least 1 of the following: * Dyspnea * Decreased exercise tolerance * Fatigue * Other symptoms of worsened end-organ perfusion or volume overload 4. Evidence of new or worsening HF consisting of at least 2 physical exam findings or 1 physical exam finding and at least 1 laboratory criterion 5. Received new or increased treatment for HF. Time to CV death or first hospitalization for worsening HF was defined as the time from randomization to the first occurrence of any component of the endpoint analyzed using KM survival analysis. Participants with no event were censored based on last non-fatal potential endpoint collection date. |
| Secondary | Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions. Ischemic stroke was defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Transient ischemic attack (TIA) was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction. Time to first ischemic fatal or non-fatal stroke or TIA was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using KM analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All randomized participants; The number of participants entered at each time point represents the number of participants at risk. | percentage of participants | NUMBER |
| SECONDARY | Time to Cardiovascular Death, Myocardial Infarction, or Stroke | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All randomized participants; The number of participants entered at each time point represents the number of participants at risk. | percentage of participants | NUMBER |
| SECONDARY | Time to Cardiovascular Death | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All randomized participants; The number of participants entered at each time point represents the number of participants at risk. | percentage of participants | NUMBER |
| SECONDARY | Time to All Cause Death | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All randomized participants; The number of participants entered at each time point represents the number of participants at risk. | percentage of participants | NUMBER |
| SECONDARY | Time to First Myocardial Infarction | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All randomized participants; The number of participants entered at each time point represents the number of participants at risk. | percentage of participants | NUMBER |
| SECONDARY | Time to First Stroke | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All randomized participants; The number of participants entered at each time point represents the number of participants at risk. | percentage of participants | NUMBER |
| SECONDARY | Time to First Coronary Revascularization | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All randomized participants; the number of participants entered at each time point represents the number of participants at risk. | percentage of participants | NUMBER |
| SECONDARY | Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All randomized participants; the number of participants entered at each time point represents the number of participants at risk. | percentage of participants | NUMBER |
| SECONDARY | Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack | Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported. | All randomized participants; the number of participants entered at each time point represents the number of participants at risk. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization | Placebo | KM estimate at 6 months | 3.11 | 95% Confidence Interval 2.82 to 3.40 | percentage of participants |
| Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization | Evolocumab | KM estimate at 6 months | 2.74 | 95% Confidence Interval 2.47 to 3.01 | percentage of participants |
| Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization | Placebo | KM estimate at 12 months | 6.01 | 95% Confidence Interval 5.61 to 6.41 | percentage of participants |
| Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization | Evolocumab | KM estimate at 12 months | 5.31 | 95% Confidence Interval 4.93 to 5.68 | percentage of participants |
| Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization | Placebo | KM estimate at 18 months | 8.32 | 95% Confidence Interval 7.86 to 8.78 | percentage of participants |
| Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization | Evolocumab | KM estimate at 18 months | 7.25 | 95% Confidence Interval 6.81 to 7.68 | percentage of participants |
| Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization | Placebo | KM estimate at 24 months | 10.66 | 95% Confidence Interval 10.12 to 11.19 | percentage of participants |
| Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization | Evolocumab | KM estimate at 24 months | 9.13 | 95% Confidence Interval 8.63 to 9.63 | percentage of participants |
| Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization | Placebo | KM estimate at 30 months | 12.72 | 95% Confidence Interval 12.08 to 13.35 | percentage of participants |
| Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization | Evolocumab | KM estimate at 30 months | 10.91 | 95% Confidence Interval 10.31 to 11.50 | percentage of participants |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 13,780 | |
| Overall Study | STARTED | Evolocumab | 13,784 | |
| Overall Study | Received Treatment | Placebo | 13,756 | |
| Overall Study | Received Treatment | Evolocumab | 13,769 | |
| Overall Study | COMPLETED | Placebo | 13,662 | |
| Overall Study | COMPLETED | Evolocumab | 13,691 | |
| Overall Study | NOT COMPLETED | Placebo | 118 | |
| Overall Study | NOT COMPLETED | Evolocumab | 93 |
Source ClinicalTrials.gov
Adverse events3,444
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 | Nasopharyngitis | Infections and infestations | Placebo | 1,021 | 13,756 | |
| other | Nasopharyngitis | Infections and infestations | Evolocumab | 1,067 | 13,769 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 649 | 13,756 | |
| other | Upper respiratory tract infection | Infections and infestations | Evolocumab | 692 | 13,769 | |
| other | Diabetes mellitus | Metabolism and nutrition disorders | Placebo | 1,096 | 13,756 | |
| other | Diabetes mellitus | Metabolism and nutrition disorders | Evolocumab | 1,156 | 13,769 | |
| other | Hypertension | Vascular disorders | Placebo | 1,157 | 13,756 | |
| other | Hypertension | Vascular disorders | Evolocumab | 1,069 | 13,769 | |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo | 27 | 13,756 | |
| serious | Anaemia | Blood and lymphatic system disorders | Evolocumab | 27 | 13,769 |
1 to 10 of 3,444Source ClinicalTrials.gov
See all 3,444 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 | 3,438 | 13,756 |
| Total, other adverse events | Evolocumab | 3,500 | 13,769 |
| Total, serious adverse events | Placebo | 3,404 | 13,756 |
| Total, serious adverse events | Evolocumab | 3,410 | 13,769 |
Source ClinicalTrials.gov
Papers30
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/NCT01764633
GET https://conductscience.org/api/trials/v1/NCT01764633/results?page=2