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

Sponsor

Mikhail Zykov (Other)

Overall Status

Recruiting

CT.gov ID

NCT06102720

Collaborator

(none)

200

Enrollment

Locations

Arms

24.7

Anticipated Duration (Months)

100

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Drug: Colchicine Drug: Clopidogrel	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 12, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Colchicine Group 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 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).
Active Comparator: Clopidogrel treatment group All patients in this arm will receive standard treatment including clopidogrel.	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).

Arm

Intervention/Treatment

Experimental: Colchicine Group

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

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).

Active Comparator: Clopidogrel treatment group

All patients in this arm will receive standard treatment including clopidogrel.

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).

Outcome Measures

Primary Outcome Measures

Any new stroke events [any time within 14 days]
Incidence of any new ischemic stroke.
Neurological deterioration [any time within 14 days]
Neurological deterioration, defined as an increase in NIHSS score of 2 or more.

Secondary Outcome Measures

New vascular events [any time within 14 days]
Incidence of any new vascular events, including ischemic stroke, myocardial infarction and vascular death
Bleeding event [any time within 14 days]
Bleeding event that is categorised as severe according to GUSTO score.
Positive functional outcome [any time within 14 days]
A positive functional outcome within 14 days is determined if the Rankin Scale score improves to 1 and 0 and/or Rivermead Mobility Index to 14 -15 points and/or Rehabilitation Routing Scale 0 -1 points.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed informed consent form by patient prior to any study-specific procedure.
Patient age over 18 years
Presence of ipsilateral lesion of the extracranial artery ≥50% according to the European measurement method ECST or its occlusion, as well as stenosis < 50% with signs of morphological instability of the atherosclerotic plaque (ulceration, hemorrhage into the plaque, intimal flotation, mural thrombus, etc.).
Minor neurological deficit (NIHSS score ≤5).
The duration of development of stroke symptoms before colchicine taken is no more than 48 hours.
Confirmation of the presence of a focus of acute ischemia in the brain according to computed tomography or magnetic resonance imaging of the brain.

Exclusion Criteria:

The presence of risk factors and conditions that determine a different pathogenetic subtype of ischemic stroke (atrial fibrillation/flutter, ventricular aneurysm, ets.).
Hemorrhagic stroke
NIHSS score ≤5.
Hospitalization of the patient more than 48 hours from the onset of the disease.
Severe anemia, thrombocytopenia, leukopenia.
Course of an infectious/viral disease.
Concomitant treatment with moderate or strong CYP3A4 inhibitors (clarithromycin, erythromycin, telithromycin, other macrolide antibiotics, ketoconazole, itraconazole, voriconazole, ritonavir, atazanavir, indinavir, other HIV protease inhibitors, verapamil or pilitin disulfazole) inhibitors (cyclosporine) at randomization.
Concomitant severe degenerative disease of the nervous system.
Concomitant inflammatory or autoimmune disease.
Dementia, established mental illness.
History of malignancy, known hepatitis B or C, or HIV infection.
Swallowing impairment interfering with oral administration of the study drug.
Pregnancy or breastfeeding. Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator.
Participation in another clinical study with an investigational product at any time during the 30 days prior to randomization
Previous enrolment or randomization in the present study.
Decrease renal function with creatinine clearance < 30 ml/min.
Presence of contraindications to taking colchicine, acetylsalicylic acid and clopidogrel.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Institute for Complex Issues of Cardiovascular Diseas	Kemerovo	Kemerovo Region	Russian Federation	650002
2	Sochi City Hospital #4	Sochi	Krasnodar Refion	Russian Federation	354057