A Phase 4 interventional study of Colchicine and Clopidogrel in Ischemic Stroke, sponsored by Mikhail Zykov. Recruiting at 2 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Mikhail Zykov · Phase 4, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 200 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Mikhail Zykov as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients in this arm will receive colchicine for 14 days in addition to standard medical care without clopidogrel (acetylsalicylic acid, lipid-lowering, antihypertensive, gastroprotective, hypoglycemic drugs if necessary, lifestyle recommendations, early rehabilitation activities).
Drug: Colchicine
All patients in this arm will receive standard treatment including clopidogrel.
Drug: Clopidogrel
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).
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).
Any new stroke events
Incidence of any new ischemic stroke.
Time frame: any time within 14 days
Neurological deterioration
Neurological deterioration, defined as an increase in The National Institutes of Health Stroke Scale (NIHSS) of 2 or more. The NIHSS provides a quantitative measure of stroke-related neurologic deficit. The higher the score, the more severe the neurological deficit.
Time frame: any time within 14 days
New vascular events
Incidence of any new vascular events, including ischemic stroke, myocardial infarction and vascular death
Time frame: any time within 14 days
Bleeding event
Bleeding event that is categorised as severe according to GUSTO (Global Utilization Of Streptokinase And Tpa For Occluded Arteries) bleeding criteria.
Time frame: any time within 14 days
Positive functional outcome
A positive functional outcome within 14 days is determined if the Modified Rankin Score (mRS) improves to 0-1 and/or Rivermead Mobility Index (RMI) to 14 -15 points and/or Rehabilitation Routing Scale 0 -1 points. The mRS is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. The RMI includes fifteen mobility items. A maximum score of 15 is possible: higher scores indicate better mobility performance. The rehabilitation routing scale is needed by the doctor to understand whether the patient requires rehabilitation. The maximum number of points is 6. The more points the patient scores, the more severe his condition.
Time frame: any time within 14 days
Plan to share: No
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