Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke

The ARCHIMEDES study (Anti-inflammatory and anti-thRombotic therapy with colCHicine and low dose rIvaroxaban for Major adverse cardiovascular Events reDuction in ischEmic Stroke) will be a randomized, double-blind, 2x2 factorial clinical trial, which will include at least 3000 and up to a maximum of 4500 patients with ischemic stroke without indication of oral anticoagulation.

Inclusion Criteria: * Patients with acute ischemic stroke aged ≥18 years old who, regardless of etiology and mechanism, do not have a definitive indication for anticoagulation, and whose symptoms onset has been within the last 14 days; * Receiving standard therapy for acute management of ischemic stroke; * For patients treated with fibrinolytics, a minimum period of 24 hours after the infusion of the lytic drug is required for randomization into the study. Exclusion Criteria: * Modified Rankin score of 4 or more at randomization; * Refusal to provide consent; * Severe renal failure, with glomerular filtration rate (by CKD-EPI) estimated at \ 1 month) with immunosuppressants or systemic corticosteroids; * History of recurrent pneumonia (3 or more hospitalizations in the last 12 months); * Pregnancy or breastfeeding; * Any other comorbidity other than stroke and CV disease (e.g., metastatic cancer) that, in the investigator's opinion, has a significant impact on the 12-month survival.