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

NCT06396858 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4500

Last updated 2026-02-11

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Alliança Diagnostic

    collaborator UNKNOWN

  • Brazilian Clinical Research Institute

    lead OTHER

Principal Investigators

  • Renato D Lopes, MD, PhD · Brazilian Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-08-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06396858 on ClinicalTrials.gov