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NOT YET RECRUITING
NCT06396858
PHASE4

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

Sponsor: Brazilian Clinical Research Institute

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4500

Start Date

2026-07

Completion Date

2027-12

Last Updated

2026-02-11

Healthy Volunteers

No

Conditions

Interventions

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.