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. 2020 Oct;10(5):1480–1507. doi: 10.21037/cdt-20-1

Table 2. Ongoing therapeutic modulation coronary imaging studies.

Study Disease cohort and enrolment estimate Intervention Modality Primary end-point Important secondary end-point(s) Estimated study completion date
Traditional therapy
   STAFENO, Han et al. (NCT02232360) Intermediate CAD, n=106 Rosuvastatin 10 mg/day plus fenofibrate 160 mg/day vs. rosuvastatin 10 mg/day for 52 weeks VH-IVUS Percent and absolute changes of Necrotic Core volume in non-culprit intermediate lesion from baseline to week 52 Change in the presence of TCFA December 2020
   ROSUZET-IVUS, Hahn et al. (NCT03169985) Symptomatic CAD, n=280 Rosuvastatin 10 mg/day plus ezetimibe 10 mg/day vs. rosuvastatin 20 mg/day for 52 weeks IVUS, OCT Change in PAV in non-culprit lesion by IVUS from baseline to week 52 Change in normalised TAV by IVUS and minimum FCT by OCT December 2023
PCSK-9 inhibitors
   ANTARES, Otake et al. (NCT03529253) Symptomatic CAD who underwent PCI, n=30 Alirocumab SC injections fortnightly plus rosuvastatin 10 mg/day vs. rosuvastatin 10 mg/day for 36 weeks NIRS maxLCBI (4 mm) in non-culprit lesion from baseline to week 36 Change in amount of LCBI September 2020
   HUYGENS, Amgen (NCT03570697) NSTE-ACS, n=150 Evolocumab SC injection monthly vs. placebo for 48 weeks OCT Absolute change in minimum FCT in matched segment of artery from baseline to week 50 Percentage change in FCT December 2020
   PACMAN-AMI, Räber et al. (NCT03067844) ACS who underwent PCI, n=220 Alirocumab SC injection fortnightly vs. placebo for 50 weeks IVUS, OCT, NIRS Change in PAV in non-culprit lesion by IVUS from baseline to week 52 Change in LCBI by NIRS and minimum FCT by OCT March 2021
   ALTAIR, Otake et al. (NCT03552432) Symptomatic CAD who underwent PCI, n=24 Alirocumab SC injection fortnightly with rosuvastatin 10 mg/day vs. rosuvastatin 10 mg/day for 36 weeks OCT Absolute change in minimum FCT in non-culprit lesion from baseline to week 36 Percentage change in FCT and plaque macrophage grade September 2021
Anti-inflammation
   COCOMO-ACS, Psaltis et al. (ACTRN 12618000809235) NSTEMI, n=82 Colchicine 0.5 mg/day vs. placebo for 52 weeks OCT Percentage change in minimum FCT in non-culprit lesion from baseline to week 52 Change in plaque lipid pool size and macrophage content June 2021

ACS, acute coronary syndrome, CAD, coronary artery disease, FCT, fibrous cap thickness; LCBI, lipid-core burden index; NSTE-ACS, non-ST-elevation acute coronary syndrome; NSTEMI, non-ST-elevation myocardial infarction; PAV, percent atheroma volume; PCSK-9, proprotein convertase subtilisin/kexin type 9, SC, subcutaneous.