NCT06102720

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Mikhail Zykov · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Colchicine	Oral colchicine will be initiated with a dose of 0.5 mg per day during 14 days. Acetylsalicylic acid was used as an antiplatelet agent (300 mg on days 1 and continuing with 100 mg/day).
DRUG	Clopidogrel	Dual antiplatelet therapy includes ASA (300 mg on days 1 and continuing with 100 mg/day) and clopidogrel (300 mg on days 1 and continuing with 75 mg/day).

Timeline

• Start date: 2023-01-12
• Primary completion: 2025-01-01
• Completion: 2025-02-01
• First posted: 2023-10-26
• Last updated: 2023-11-07

Locations

2 sites across 1 country: Russia