NCT06396858

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

A 2 x 2 Factorial Randomized Clinical Trial Evaluating Anti-inflammatory and Anti-thrombotic Strategy in Acute Ischemic Stroke

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4,500 (estimated)
• Sponsor: Brazilian Clinical Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Rivaroxaban 2.5 Mg Oral Tablet	Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.
DRUG	Colchicine 0.5 MG	Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.
DRUG	Placebo Rivaroxaban	Patients will receive one tablet, per oral or orogastric route, twice a day, for a maximum of 12 months.
DRUG	Placebo Colchicine	Patients will receive one tablet, per oral or orogastric route, once a day, for a maximum of 12 months.

Timeline

• Start date: 2026-07-01
• Primary completion: 2027-08-01
• Completion: 2027-12-01
• First posted: 2024-05-02
• Last updated: 2026-02-11