Aernoud Fiolet

275 Colchicine reduces extracellular vesicle NLRP3 inflammasome protein levels Laboratory assessment in LoDoCo2 participants A total of 338 patients provided written informed consent and started the open- label run in phase. Forty-five patients (13.0%) were not randomized, most often due to perceived side effects (7.0%). All 293 patients that were randomized received at least one dose of the trial medication. With the exception of one participant, who died due to a non-cardiovascular cause, all patients were available for follow up at one year. In 7 patients in the colchicine group and in 7 patients in the placebo group, no blood sample could be obtained due to logistical reasons or on patient request. A total of 278 samples (n=138 in the colchicine group and n=140 in the placebo group) were available for analyses. A detailed flowchart is displayed in Figure 2. The baseline characteristics of the patients were well balanced between groups. There were more women in the colchicine group (19.3%) compared to the placebo group (14.2%). Patients were well treated according to contemporary secondary prevention strategies (Table 1). Figure 2. Enrollment, Randomization, and Follow-up. The figure shows the selection of subjects and reasons for exclusion.