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.
In patients with ischemic stroke, within 14 days of symptom onset, to establish the efficacy and safety of two strategies in parallel: low-dose rivaroxaban and low-dose colchicine, compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
4,500
Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.
Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.
Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.
Primary efficacy endpoint: Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial
Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial revascularization
Time frame: 12 months
Primary safety endpoint (rivaroxaban versus placebo): Time to major bleeding according to the International Society of Thrombosis and Hemostasis classification
Time to major bleeding according to the International Society of Thrombosis and Hemostasis classification
Time frame: 12 months
Primary safety endpoint (colchicine versus placebo): Hospitalization for respiratory infections
Time to first hospitalization for respiratory infections
Time frame: 12 months
Time to fatal or non-fatal stroke
Time to fatal or non-fatal stroke
Time frame: 12 months
Time to CV death, MI, or stroke
Time to CV death, MI, or stroke
Time frame: 12 months
Time to death from all causes, MI, or stroke
Time to death from all causes, MI, or stroke
Time frame: 12 months
Time to fatal or non-fatal stroke, death, or transient ischemic attack
Time to fatal or non-fatal stroke, death, or transient ischemic attack
Time frame: 12 months
Net clinical endpoint: time to CV death, MI, stroke, fatal bleeding, or critical site bleeding
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Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.
Time to CV death, MI, stroke, fatal bleeding, or critical site bleeding
Time frame: 12 months
Time to all-cause death
Time to all-cause death
Time frame: 12 months