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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrazilian Clinical Research Institute

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

4,500 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators