Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102720
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-10-22
Brief Title:
Efficacy of Colchicine in Preventing Recurrent Stroke in the Patients With Acute Atherothrombotic Ischemic Stroke During Hospitalization
Sponsor:
Mikhail Zykov
Organization:
Research Institute for Complex Problems of Cardiovascular Diseases Russia
Study Overview
Official Title:
Two-center Prospective Randomized Open-label Controlled Clinical Trial With Endpoint Evaluation
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLCHIDA
Brief 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 11 ratio Patients in one arm will receive colchicine initiated with a dose of 05 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None