Using low-dose colchicine to prevent recurrent strokes in hospitalized patients with ischemic stroke

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

This study is testing if a low dose of colchicine can help prevent more strokes in hospitalized patients who have just had a minor to moderate ischemic stroke.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia (Academic / other)
• Locations: 2 sites (Kemerovo, Kemerovo Region and 1 other locations)
• Trial ID: NCT06102720 on ClinicalTrials.gov

What this trial studies

This is a two-center, prospective, randomized, open-label, controlled study investigating the efficacy of low-dose colchicine in preventing recurrent strokes in patients with acute atherothrombotic minor-to-moderate ischemic stroke during hospitalization. Eligible patients will be randomly assigned to receive either colchicine or standard care, with colchicine administered at a dose of 0.5 mg per day for 14 days. The study will assess outcomes such as recurrent stroke, neurological deterioration, and combined endpoint events including myocardial infarction and death. Follow-up visits will occur at discharge to evaluate the effectiveness of the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years with acute atherothrombotic ischemic stroke and specific imaging-confirmed arterial lesions.

Not a fit: Patients with hemorrhagic stroke or those with other specific risk factors for different stroke subtypes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the risk of recurrent strokes in patients hospitalized for ischemic stroke.

How similar studies have performed: While colchicine has been studied for other cardiovascular conditions, this specific application for recurrent stroke prevention is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Signed informed consent form by patient prior to any study-specific procedure.
2. Patient age over 18 years
3. 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.).
4. Minor neurological deficit (NIHSS score ≤5).
5. The duration of development of stroke symptoms before colchicine taken is no more than 48 hours.
6. 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:

1. The presence of risk factors and conditions that determine a different pathogenetic subtype of ischemic stroke (atrial fibrillation/flutter, ventricular aneurysm, ets.).
2. Hemorrhagic stroke
3. NIHSS score ≤5.
4. Hospitalization of the patient more than 48 hours from the onset of the disease.
5. Severe anemia, thrombocytopenia, leukopenia.
6. Course of an infectious/viral disease.
7. 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.
8. Concomitant severe degenerative disease of the nervous system.
9. Concomitant inflammatory or autoimmune disease.
10. Dementia, established mental illness.
11. History of malignancy, known hepatitis B or C, or HIV infection.
12. Swallowing impairment interfering with oral administration of the study drug.
13. 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.
14. Participation in another clinical study with an investigational product at any time during the 30 days prior to randomization
15. Previous enrolment or randomization in the present study.
16. Decrease renal function with creatinine clearance \< 30 ml/min.
17. Presence of contraindications to taking colchicine, acetylsalicylic acid and clopidogrel.

Where this trial is running

Kemerovo, Kemerovo Region and 1 other locations

• Research Institute for Complex Issues of Cardiovascular Diseas — Kemerovo, Kemerovo Region, Russian Federation (Recruiting)
• Sochi City Hospital #4 — Sochi, Krasnodar Refion, Russian Federation (Recruiting)

Conditions Ischemic Stroke; ischemic stroke; low-dose colchicine; clopidogrel