Trial · NCT02993406
Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo
NCT02993406, Phase 3, Completed, Esperion Therapeutics, Inc.; results first posted 2024-01-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo. Trials, record NCT02993406. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02993406
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo
- NCT number
- NCT02993406
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 13,970 participants, actual
- Lead sponsor
- Esperion Therapeutics, Inc.
- Conditions
- Cardiovascular Diseases, Statin Adverse Reaction
- Interventions
- Bempedoic acid 180 mg tablet, Matching placebo tablet
- First posted
- 2016-12-15
- Last updated
- 2024-01-03
- Results first posted
- 2024-01-03
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE) | Up to 68 months | The primary efficacy end point was a four-component composite of adjudicated MACE, defined as death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization, as assessed in a time-to first-event analysis. |
| Secondary | Number of Participants With First Occurrence of Three Component MACE | Up to 68 months | The first key secondary end point was a three-component MACE, defined as death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. |
| Secondary | Number of Participants With First Occurrence of Myocardial Infarction | Up to 68 months | Number of participants with time to first occurrence of fatal and non-fatal myocardial infarction are presented. |
| Secondary | Number of Participants With Time to First Occurrence of Coronary Revascularization | Up to 68 months | Number of participants with time to first occurrence of coronary revascularization are presented. |
| Secondary | Number of Participants With Time to First Occurrence of Stroke | Up to 68 months | Number of participants with time to first occurrence of fatal and non-fatal stroke. |
| Secondary | Number of Participants With Time to Cardiovascular Death | Up to 68 months | Number of participants with time to cardiovascular death are presented. |
| Secondary | Number of Participants With Time to All-cause Mortality | Up to 68 months | All-cause mortality is death due to any cause. Number of participants with time to all-cause mortality are presented. |
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 | Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE) | Up to 68 months | Intention-to-Treat Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With First Occurrence of Three Component MACE | Up to 68 months | Intention-to-Treat Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With First Occurrence of Myocardial Infarction | Up to 68 months | Intention-to-Treat Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Time to First Occurrence of Coronary Revascularization | Up to 68 months | Intention-to-Treat Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Time to First Occurrence of Stroke | Up to 68 months | Intention-to-Treat Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Time to Cardiovascular Death | Up to 68 months | Intention-to-Treat Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Time to All-cause Mortality | Up to 68 months | Intention-to-Treat Population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE) | Bempedoic Acid 180 mg | 819 | Participants | ||
| Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE) | Placebo Comparator | 927 | Participants | ||
| Number of Participants With First Occurrence of Three Component MACE | Bempedoic Acid 180 mg | 575 | Participants | ||
| Number of Participants With First Occurrence of Three Component MACE | Placebo Comparator | 663 | Participants | ||
| Number of Participants With First Occurrence of Myocardial Infarction | Bempedoic Acid 180 mg | 261 | Participants | ||
| Number of Participants With First Occurrence of Myocardial Infarction | Placebo Comparator | 334 | Participants | ||
| Number of Participants With Time to First Occurrence of Coronary Revascularization | Bempedoic Acid 180 mg | 435 | Participants | ||
| Number of Participants With Time to First Occurrence of Coronary Revascularization | Placebo Comparator | 529 | Participants | ||
| Number of Participants With Time to First Occurrence of Stroke | Bempedoic Acid 180 mg | 135 | Participants | ||
| Number of Participants With Time to First Occurrence of Stroke | Placebo Comparator | 158 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bempedoic Acid 180 Milligrams (mg) | 6,992 | |
| Overall Study | STARTED | Placebo Comparator | 6,978 | |
| Overall Study | COMPLETED | Bempedoic Acid 180 Milligrams (mg) | 6,697 | |
| Overall Study | COMPLETED | Placebo Comparator | 6,620 | |
| Overall Study | NOT COMPLETED | Bempedoic Acid 180 Milligrams (mg) | 295 | |
| Overall Study | NOT COMPLETED | Placebo Comparator | 358 |
Source ClinicalTrials.gov
Adverse events2,412
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 | COVID-19 | Infections and infestations | Bempedoic Acid 180 mg | 731 | 7,001 | 756 |
| other | COVID-19 | Infections and infestations | Placebo Comparator | 801 | 6,964 | 826 |
| other | Urinary tract infection | Infections and infestations | Bempedoic Acid 180 mg | 539 | 7,001 | 802 |
| other | Urinary tract infection | Infections and infestations | Placebo Comparator | 515 | 6,964 | 784 |
| other | Nasopharyngitis | Infections and infestations | Bempedoic Acid 180 mg | 351 | 7,001 | 424 |
| other | Nasopharyngitis | Infections and infestations | Placebo Comparator | 389 | 6,964 | 462 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Bempedoic Acid 180 mg | 548 | 7,001 | 675 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo Comparator | 554 | 6,964 | 722 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Bempedoic Acid 180 mg | 404 | 7,001 | 458 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo Comparator | 450 | 6,964 | 511 |
1 to 10 of 2,412Source ClinicalTrials.gov
See all 2,412 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bempedoic Acid 180 mg | 437 | 7,001 |
| Total, all-cause mortality | Placebo Comparator | 420 | 6,964 |
| Total, other adverse events | Bempedoic Acid 180 mg | 5,805 | 7,001 |
| Total, other adverse events | Placebo Comparator | 5,490 | 6,964 |
| Total, serious adverse events | Bempedoic Acid 180 mg | 1,767 | 7,001 |
| Total, serious adverse events | Placebo Comparator | 1,733 | 6,964 |
Source ClinicalTrials.gov
Papers16
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 comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Bempedoic Acid 180 mg vs Placebo Comparator: Number of Participants With Time to Cardiovascular Death | Trial comparisons |
| Bempedoic Acid 180 mg vs Placebo Comparator: Number of Participants With First Occurrence of Myocardial Infarction | Trial comparisons |
| Bempedoic Acid 180 mg vs Placebo Comparator: Number of Participants With Time to First Occurrence of Stroke | Trial comparisons |
| Bempedoic Acid 180 mg vs Placebo Comparator: Number of Participants With First Occurrence of Three Component MACE | Trial comparisons |
| Bempedoic Acid 180 mg vs Placebo Comparator: Number of Participants With Time to All-cause Mortality | Trial comparisons |
| Bempedoic Acid 180 mg vs Placebo Comparator: Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE) | Trial comparisons |
| Bempedoic Acid 180 mg vs Placebo Comparator: Number of Participants With Time to First Occurrence of Coronary Revascularization | Trial comparisons |
| Bempedoic Acid 180 mg vs Placebo Comparator: deaths from any cause | Trial comparisons |
| Bempedoic Acid 180 mg vs Placebo Comparator: 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/NCT02993406
GET https://conductscience.org/api/trials/v1/NCT02993406/events?page=2