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Efficacy of Colchicine in Preventing Recurrent Stroke in the Patients With Acute Atherothrombotic Ischemic Stroke During Hospitalization — COLCHIDA  

Ischemic Stroke Clinical Trial

Official title:
Two-center, Prospective, Randomized, Open-label, Controlled Clinical Trial With Endpoint Evaluation

Clinical Trial Summary

This study is two-center, prospective, randomized, open-label, controlled, investigator-sponsored study that aims to investigate the efficacy of low-dose colchicine in preventing recurrent stroke in the patients with acute atherothrombotic minor-to-moderate ischemic stroke during hospitalization.

Clinical Trial Description

This study is two-center, prospective, randomized, open-label, controlled, investigator-sponsored study that aims to investigate the efficacy of low-dose colchicine in preventing recurrent stroke in the patients with acute atherothrombotic minor-to-moderate ischemic stroke during hospitalization. Patients who were eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into two groups by a 1:1 ratio. Patients in one arm will receive colchicine initiated with a dose of 0.5 mg per day during on days 1 through 14. Study visits will be performed on the day of randomization and at discharge. The outcomes were stroke, neurological deterioration, сombined endpoint events (stroke, myocardial infarction and death), bleeding during 14 days of follow-up in an intention-to treat analysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06102720
Study type Interventional
Source Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Contact
Status Recruiting
Phase Phase 4
Start date January 12, 2023
Completion date February 1, 2025
View Details
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