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

NCT06102720 | Unknown Phase 4

• 1 other identifier: COLCHIDA_1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Ischemic Stroke

Keywords

ischemic stroke; low-dose colchicine; clopidogrel

Outcome Measures

Primary Outcomes (2)

• Any new stroke events

  Incidence of any new ischemic stroke.

  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.

  any time within 14 days

Secondary Outcomes (3)

• New vascular events

  any time within 14 days

• Bleeding event

  any time within 14 days

• Positive functional outcome

  any time within 14 days

Study Arms (2)

Colchicine Group

EXPERIMENTAL

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

Clopidogrel treatment group

ACTIVE COMPARATOR

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

Drug: Clopidogrel

Interventions

Colchicine DRUG

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).

Colchicine Group

Clopidogrel DRUG

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).

Clopidogrel treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mikhail Zykov: lead

Study Sites (2)

Research Institute for Complex Issues of Cardiovascular Diseas

Kemerovo, Kemerovo Oblast, 650002, Russia

RECRUITING

Sochi City Hospital #4

Sochi, Krasnodar Refion, 354057, Russia

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Colchicine; Clopidogrel

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 26, 2023
• Study Start: January 12, 2023
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)