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NCT06396858Not yet recruiting

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
Brazilian Clinical Research InstitutePhase 4ClinicalTrials.govdrug
Study focus
Disease/Condition
Ischemic Stroke
Drug/Device/Intervention
Rivaroxaban 2.5 Mg Oral Tablet
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Brazilian Clinical Research Institute
Timeline & enrollment
Phase
Phase 4
Start date
Jul 01, 2024
End date
Dec 01, 2026
Enrollment
4500 participants
Primary outcome

Primary efficacy endpoint: Time to cardiovascular death, stroke, myocardial infarction (MI), or urgent arterial,Primary safety endpoint (rivaroxaban versus placebo): Time to major bleeding according to the International Society of Thrombosis and Hemostasis classification,Primary safety endpoint (colchicine versus placebo): Hospitalization for respiratory infections

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.

ICD-10 classifications
Stroke, not specified as haemorrhage or infarctionSequelae of stroke, not specified as haemorrhage or infarctionCerebral infarctionCerebral infarction, unspecifiedOther cerebral infarction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06396858
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06396858 through Pure Global AI's free database. This Phase 4 trial is sponsored by Brazilian Clinical Research Institute and is currently Not yet recruiting. The study focuses on Ischemic Stroke. Target enrollment is 4500 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.