Trial · NCT07474649
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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. |
| Secondary | Mean absolute changes in atherosclerosis-related biomarker high-density lipoprotein cholesterol (HDL-C) | 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 non-high-density lipoprotein cholesterol (non-HDL-C) | 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 biomarkers lipoprotein a (Lp(a)) and apolipoprotein B (apoB) | 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 high-sensitive C reactive protein (hs-CRP) | Baseline up to 12 months | This endpoint will evaluate the biochemical impact of triple therapy on critical biomarkers associated with atherosclerosis. |
| Secondary | Annualised changes in Framingham steatosis index (FSI) and fibrosis-4 (Fib-4) | Baseline up to 12 months | This endpoint will assess the potential impact of the triple therapy on measures of liver health. |
| Secondary | Cumulative incidence of adverse events (AEs) under triple therapy during the trial | Baseline up to 12 months | This endpoint will monitor and assess adverse events (AEs) under triple treatment. |
| Secondary | Rate of treatment discontinuation during the trial | Baseline up to 12 months | This endpoint will to determine the rate and reasons for treatment discontinuation among trial participants receiving triple therapy. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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