About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 <15 mL/min/1.73 m2;
Severe liver failure (child C);
Trial design
Treatments tested in this trial
- Rivaroxaban 2.5 Mg Oral Tablet
- Colchicine 0.5 MG
- Placebo Rivaroxaban
- Placebo Colchicine
Treatment groups
Locations
Sponsors and collaborators
Brazilian Clinical Research Institute
Lead sponsor
Alliança Diagnostic
Collaborator