Clinical trial NCT06102720: Efficacy of Colchicine in Preventing Recurrent Stroke in the Patients With Acute Atherothrombotic Ischemic Stroke During Hospitalization
Official title: Two-center, Prospective, Randomized, Open-label, Controlled Clinical Trial With Endpoint Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ischemic Stroke
Keywords: ischemic stroke
low-dose colchicine
clopidogrel
Lead sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Any new stroke events
timeFrame: any time within 14 days
measure: Neurological deterioration
timeFrame: any time within 14 days
Secondary outcomes:
measure: New vascular events
timeFrame: any time within 14 days
measure: Bleeding event
timeFrame: any time within 14 days
measure: Positive functional outcome
timeFrame: any time within 14 days
Other outcomes:
Locations:
city: Kemerovo
country: Russian Federation
facility: Research Institute for Complex Issues of Cardiovascular Diseas
state: Kemerovo Region
city: Sochi
country: Russian Federation
facility: Sochi City Hospital #4
state: Krasnodar Refion
Study officials:
References: