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A 2 x 2 Factorial Randomized Clinical Trial Evaluating Anti-inflammatory and Anti-thrombotic Strategy in Acute Ischemic Stroke (ARCHIMEDES)
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.
Details
| Lead sponsor | Brazilian Clinical Research Institute |
|---|---|
| Phase | Phase 4 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 4500 |
| Start date | 2026-07 |
| Completion | 2027-12 |
Conditions
- Ischemic Stroke
Interventions
- Rivaroxaban 2.5 Mg Oral Tablet
- Colchicine 0.5 MG
- Placebo Rivaroxaban
- Placebo Colchicine
Primary outcomes
- Primary efficacy endpoint: Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial — 12 months
Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial revascularization - Primary safety endpoint (rivaroxaban versus placebo): Time to major bleeding according to the International Society of Thrombosis and Hemostasis classification — 12 months
Time to major bleeding according to the International Society of Thrombosis and Hemostasis classification - Primary safety endpoint (colchicine versus placebo): Hospitalization for respiratory infections — 12 months
Time to first hospitalization for respiratory infections