Acute myocardial infarction
Conditions
Brief summary
Change in percent atheroma volume (PAV) as determined by greyscale IVUS in matched regions of interest. Measured from randomisation to end-of-study.
Detailed description
Change in maximum lipid core burden index (LCBI) in any 4-mm segment (maxLCBI4mm) as determined by NIRS in matched regions of interest. Measured from randomisation to end-of-study., Change in minimal fibrous cap thickness as determined by OCT in matched regions of interest. Measured from randomisation to end-of-study., Change in LCBI total as determined by NIRS in matched regions of interest. Measured from randomisation to end-of-study., Change in average angular extension (AAE) of macrophages as determined by OCT in matched regions of interest. Change in LCBI total as determined by NIRS in matched regions of interest. Measured from randomisation to end-of-study., Change in normalized total atheroma volume (NTAV) by IVUS in matched regions of interest. Measured from randomisation to end-of-study., Change in mean fibrous cap thickness as determined by OCT in matched regions of interest. Measured from randomisation to end-of-study., Change in IL-6. Measured from randomisation to week 4 and week 52., Change in hs-CRP. Measured from randomisation to to week 4 and week 52., Change in hs-TnT . Measured from randomisation to week 4 and week 52., Change in NT-pro-BNP . Measured from randomisation to week 4 and week 52., Change in lipid and inflammatory markers. Measured from randomisation to week 4 and week 52., Time to first occurrence of: All-cause death Cardiac death Non-fatal spontaneous myocardial infarction Any coronary revascularizationa Non-fatal stroke Transient ischemic attack Measured from randomisation to end-of-study.
Interventions
Sponsors
Novo Nordisk A/S, ECRI-trials B.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in percent atheroma volume (PAV) as determined by greyscale IVUS in matched regions of interest. Measured from randomisation to end-of-study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in maximum lipid core burden index (LCBI) in any 4-mm segment (maxLCBI4mm) as determined by NIRS in matched regions of interest. Measured from randomisation to end-of-study., Change in minimal fibrous cap thickness as determined by OCT in matched regions of interest. Measured from randomisation to end-of-study., Change in LCBI total as determined by NIRS in matched regions of interest. Measured from randomisation to end-of-study., Change in average angular extension (AAE) of macrophages as determined by OCT in matched regions of interest. Change in LCBI total as determined by NIRS in matched regions of interest. Measured from randomisation to end-of-study., Change in normalized total atheroma volume (NTAV) by IVUS in matched regions of interest. Measured from randomisation to end-of-study., Change in mean fibrous cap thickness as determined by OCT in matched regions of interest. Measured from randomisation to end-of-study., Change in IL-6. Measured from randomisation to week 4 a | — |
Countries
Austria, Denmark, Italy, Netherlands, Spain
Outcome results
None listed