Trial · NCT07474649
A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
NCT07474649, Phase 3, Not yet recruiting, Daiichi Sankyo
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events. Trials, record NCT07474649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07474649
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events
- NCT number
- NCT07474649
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 103 participants, estimated
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Coronary Atherosclerosis, Mixed Dyslipidemia, Hypercholesterolemia
- Interventions
- Bempedoic acid, Ezetimibe, Rosuvastatin, Atorvastatin
- First posted
- 2026-03-16
- Last updated
- 2026-09-29
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualised change in percentage plaque burden (Δ%PB) | Baseline up to 12 months | This endpoint will evaluate the effectiveness of the triple therapy in reducing plaque burden (PB). |
| Secondary | Key Secondary: Annualised change in normalised non-calcified plaque volume (PV) | Baseline up to 12 months | This endpoint will assess the efficacy of the triple therapy by evaluating changes in plaque composition and morphology. |
| Secondary | Percentage of participants with regression in normalised total plaque volume (TPV), normalised non-calcified PV, and normalised low attenuation PV at EoT (i.e., ΔPV and Δnon-calcified PV, and Δlow-attenuation PV) | Baseline up to 12 months | This endpoint will evaluate the potential impact of the triple therapy on total plaque volume (TPV) regression, non-calcified PV regression, and low attenuation PV regression. |
| Secondary | Change in the absolute Agatston coronary artery calcium (CAC) score | Baseline up to 12 months | This endpoint will evaluate the potential impact of the triple therapy on coronary calcification. CAC measures the total area and density of calcified plaque in the heart's arteries, ranging from 0 to over 400. A score of 0 indicates no plaque, while higher scores indicate increased risk of cardiovascular events, with \>400 indicating extensive disease. |
| Secondary | Annualised ΔTotal Plaque Volume (TPV) | Baseline up to 12 months | This endpoint will evaluate the effectiveness of the triple therapy in reducing TPV. |
| Secondary | Percentage of participants with regression in TPV (i.e., negative ΔTPV) | Baseline up to 12 months | This endpoint will assess the proportion of participants exhibiting regression in TPV with triple therapy. |
| Secondary | Absolute annualised change in fractional flow reserve derived from computed tomography (FFRCT) of the vessel with the lowest FFR at Baseline | Baseline up to 12 months | This endpoint will assess changes in non-invasive coronary flow reserve. |
| Secondary | Absolute annualised change in FFRCT of the average of 3 main epicardial coronary arteries (left anterior descending artery [LAD], circumflex artery [Cx], right coronary artery [RCA]) | Baseline up to 12 months | This endpoint will assess changes in non-invasive coronary flow reserve. |
| Secondary | Mean absolute changes in atherosclerosis-related biomarker total cholesterol | Baseline up to 12 months | This endpoint will evaluate the biochemical impact of triple therapy on critical biomarkers associated with atherosclerosis. |
| Secondary | Mean absolute changes in atherosclerosis-related biomarker low-density lipoprotein cholesterol (LDL-C) | Baseline up to 12 months | This endpoint will evaluate the biochemical impact of triple therapy on critical biomarkers associated with atherosclerosis. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT07474649
GET https://conductscience.org/api/trials/v1/NCT07474649/registered