Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke - Trial NCT06396858
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.
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Study Focus
Sponsor & Location
Brazilian Clinical Research Institute
Timeline & Enrollment
Phase 4
Jul 01, 2024
Dec 01, 2026
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
Data Source
ClinicalTrials.gov
NCT06396858
Non-Device Trial